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regarding Pseudomonas fluorescens
bloodstream infections. If you have been
hospitalized due to a bacterial infection
that you believe was caused by IV Flush
and distributed by Pinnacle Medical
Supply, contact me as soon as possible
for legal representation. You must act
soon to protect your rights.

Recent news:

MMWR reprint: Pseudomonas bloodstream
infections associated with a heparin/saline flush
--- Missouri, New York, Texas, and Michigan,
2004--2005

(30 March 2005: VIDYYA MEDICAL NEWS
SERVICE) -- On 26 January 2005, CDC was
notified of four cases of Pseudomonas
fluorescens bloodstream infection among
patients at an oncology clinic in Missouri. All
patients had received a heparin/saline flush to
prevent clotting of indwelling, central venous
catheters. The flushes were preloaded in syringes
by IV Flush and distributed by Pinnacle Medical
Supply (Rowlett, Texas). On January 31, a
nationwide alert against use of all heparin or
saline flushes preloaded in syringes by IV Flush
was issued by the Food and Drug Administration;
the company recalled these products. As of
February 15, state and local health departments
and CDC had identified a total of 36
Psuedomonas species infections in patients in
four states who were administered the
heparin/saline flushes from multiple lots. This
report describes the ongoing investigation and
provides recommendations for investigation and
management of potential cases.
Missouri

During December 29, 2004--February 1, 2005, a
hospital physician diagnosed nine cases of P.
fluorescens infection; eight were in patients at an
oncology clinic, and one was in a patient
hospitalized with sickle cell disease. Median age
of the nine patients was 57 years (range: 32--72
years). Of the eight patients with cancer, three
(38%) had received stem-cell transplants within 6
months of infection. All nine patients had
long-term, indwelling, central venous catheters
and had received heparin/saline flush prepared
by IV Flush, usually in 10 mL syringes. Patients
had either fever or fever and chills within 2--26
days after their catheters were flushed. Blood
cultures drawn through the catheters grew P.
fluorescens; simultaneous, peripheral blood
cultures did not grow the organism. In one
patient, a tissue sample from the area
surrounding the catheter grew P. fluorescens. In
addition, cultures of unopened heparin/saline
syringes from IV Flush grew P. fluorescens in the
laboratory of the hospital. Catheters were
removed, and the patients were treated with
intravenous and/or oral antibiotics; all patients
recovered from their infections.
New York

On February 4, 2005, a hospital notified the New
York City Department of Health and Mental
Hygiene (NYCDOHMH) and the New York State
Department of Health (NYSDOH) of six cases of
P. fluorescens infections in children with central
venous catheters. All six patients had received
heparin/saline flush, preloaded in syringes by IV
Flush. NYSDOH and NYCDOHMH immediately
alerted providers and laboratories and asked
them to perform surveillance for cases of
bacteremia or sepsis with P. fluorescens and to
submit isolates to their public health laboratories
for confirmation and molecular typing.
Surveillance of cases during December 13,
2004--February 8, 2005, resulted in identification
of 12 cases of P. fluorescens infections. All 12
patients were children; median age was 9 years
(range: 8 months--18 years). All 12 had long-term,
indwelling, central venous catheters and had
been administered heparin/saline flush,
preloaded in syringes by IV Flush. Blood cultures
were obtained through the catheters in 10
patients (83%) and from peripheral sites in three
patients (25%). Of the 12 patients, 10 (83%) had
cancer, one had cystic fibrosis, and one had an
X-linked immunodysregulatory disease. All the
patients had fever, and three (25%) had
hypotension. Nine (75%) were admitted to the
hospital for treatment with intravenous
antibiotics, and one required admission to the
intensive care unit for management of
hypotension; seven (58%) had recurring febrile
episodes. All 12 patients were treated with
antibiotics; six (50%) patients also required
catheter removal. All 12 patients recovered.
Cultures of unopened heparin/saline syringes
from IV Flush grew P. fluorescens in the New York
State Public Health Laboratory.
Texas

During December 12, 2004--February 5, 2005,
physicians diagnosed 14 Pseudomonas species
bloodstream infections (11 P. fluorescens and
three unknown Pseudomonas species) among
patients in one hospital. The 14 patients had
been admitted for various conditions, including
seizure, colon cancer, pneumonia, urinary-tract
infection, and sepsis. Median age of the patients
was 50 years (range: 16 days--86 years). All
patients had either short- or long-term,
indwelling, central venous catheters and had
received heparin/saline flush prepared by IV
Flush. In all cases, the Pseudomonas species
were recovered from peripheral blood cultures.
All patients had fever during their hospital stays;
all were treated with intravenous antibiotics, and
peripherally inserted central catheters and
central venous lines were removed. Thirteen
(93%) of the patients recovered; one infant
remained hospitalized as of March 22, but the
continued hospitalization was not related to the
infection. Cultures of unopened heparin/saline
syringes from IV Flush grew P. fluorescens in the
hospital laboratory. Pulsed-field gel
electrophoresis (PFGE) testing at the Texas State
Public Health Laboratory revealed that isolates
from eight patients and an unopened
heparin/saline syringe from IV Flush were
indistinguishable by one enzyme.
Michigan

In January 2005, a patient with a chronic,
indwelling, central venous catheter had onset of
chills and fever several hours after the catheter
had been used during a surgical procedure. The
patient had received a heparin/saline flush,
prepared by IV Flush, at a local clinic during the
preceding week. Blood cultures were obtained
through the catheter and grew P. fluorescens.
The patient was treated with antibiotics and
recovered.
Investigation of IV Flush

A trace-back investigation by state and local
health departments and CDC determined that IV
Flush was the source of the heparin/saline flush
administered in preloaded syringes to all patients
with P. fluorescens infections. To produce its
heparin/saline flush, IV Flush ordered heparin
powder and sent it to a compounding pharmacy,
where a concentrated heparin solution was
made. This concentrated solution was then
returned to IV Flush, where it was added to bags
of saline solution, from which the syringes were
filled. Sterility testing of the concentrated
heparin solution by IV Flush was reportedly not
performed. After discovering that the
heparin/saline flush was contaminated, the
physician in Missouri informed IV Flush and the
Missouri State Department of Health and Senior
Services. The state health department notified
CDC, which notified FDA, and IV Flush
subsequently initiated a nationwide recall. On
January 31, 2005, FDA issued an alert against
use of the flush and subsequently issued an
updated alert on February 4 (1).

Samples of unopened heparin/saline flush
syringes were sent to CDC, where bacterial
cultures of seven of nine lots grew P. fluorescens.
CDC also plans to conduct PFGE tests on isolates
from all four states; as of March 22, the only
molecular typing results were from the Texas
State Public Health Laboratory. Information
obtained by FDA indicated that the
heparin/saline flush might have been distributed
to locations in as many as 17 states during the
preceding year. CDC continues to work with state
and local health departments and FDA to ensure
that heparin/saline syringes from IV Flush are no
longer in use in these locations and to search for
additional cases.

Reported by: DJ Kennedy, MD, P Masidonski, EM
Swierkosz, PhD, Saint Louis Univ; K Davidson,
MPH, City of St. Louis Dept of Health; D Dodson,
MS, Missouri State Dept of Health and Senior
Svcs. BT Edwards, MD, EM Vellozzi, Albert
Einstein College of Medicine; PD Latta, PhD, P
Graham, MD, O Mitano, PhD, M O'Keefe, MPH, J
Marcus, MD, A Lee, MD, L Saiman, MD,
Columbia Univ, New York-Presbyterian Hospital,
New York City; D Olson, MPH, LV Lee, MS, D
Weiss, MD, New York City Dept of Health and
Mental Hygiene; A Genovese-Cendela, MBA, A
Greenberg, MD, M Sherman, Nassau County Dept
of Health, Mineola; B Harper, MD, D Graham,
MD, P Dillon, MD, L Barlow, MS, J Bolta, J Esser,
MPH, J Schweitzer, Suffolk County Dept of
Health Svcs, North Babylon; W Terry, MPH, A
Huang, MD, J Lipsman, MD, Westchester County
Dept of Health, New Rochelle; D Kohlerschmidt,
A Carpenter, S Jose, N Dumas, Wadsworth Center
Laboratory; J Greenko, MPH, P Kurpiel, MPH, R
Gallo, M Kacica, MD, G Johnson, P Smith, New
York State Dept of Health. PJ White, C Weindorf,
Medical Center of Lewisville, Lewisville; J
Gullion, PhD, Denton County Health Dept,
Denton; N Pascoe, M Richardson, Texas Dept of
State Health Svcs Laboratory. EV Wells, MD, MJ
Wilkins, DVM, Michigan Dept of Community
Health. Food and Drug Admin. A Srinivasan, MD,
D Jernigan, MD, E Meites, MPH, B Jensen,
MMSc, J Noble-Wang, PhD, M Arduino, PhD, Div
of Healthcare Quality Promotion, National Center
for Infectious Diseases; S Stonecipher, DVM, Div
of Public Health Partnerships, National Center for
Health Marketing; S Benoit, MD, EIS Officer,
CDC.
Editorial Note:

The findings from this ongoing investigation
indicate that heparin/saline flush, preloaded in
syringes by IV Flush, was contaminated with P.
fluorescens during commercial preparation and
administered to multiple patients in at least four
states. Exposure to the contaminated flush has
been associated with infections in 36 patients;
additional potential cases are under
investigation. Most of the patients had serious
underlying medical conditions and subsequently
had bloodstream infections; many required
hospitalization and surgical removal of
long-term, indwelling, catheters. CDC, FDA, and
state and local health departments continue their
efforts to ensure that the recalled syringes are no
longer being used.

P. fluorescens is a member of the fluorescent
pseudomonad bacteria group and is an
infrequent cause of blood stream infections.
Optimal temperature range for growing the
organism is 77ºF--86ºF (25ºC--30ºC); P.
fluorescens can be difficult to grow when
samples are incubated at 98.6ºF (37ºC), the
temperature at which most bacterial cultures are
incubated in hospital microbiology laboratories
(2). Depending on laboratory capabilities,
identification of P. fluorescens can be difficult;
therefore, patients who received the
heparin/saline flush and were infected with
unidentified Pseudomonas species were
included in the case count in this report.

FDA is investigating the source of contamination
in this outbreak, which might have occurred
either at IV Flush or at the compounding
pharmacy that prepared the heparin solution.
Preparation of drug products to fill prescriptions
for specifically designated patients is considered
pharmaceutical compounding, not
manufacturing. However, companies that prepare
products not requested by a prescription are
considered manufacturers and should follow
requirements set forth by FDA regulations on
good manufacturing practices (3). These
regulations help ensure the sterility of products
intended for injection and include requirements
for measures such as validation of sterilization
techniques and sterility testing of finished
products. In this case, sterility testing of the
finished product was reportedly not performed.
Had it been done, the contamination that led to
this outbreak might have been detected before
the product was distributed.

Contaminated products prepared in
compounding pharmacies have also been
implicated in previous clusters of infections,
including Exophiala dermatiditis joint infections
caused by injectable steroids (4); Chryseomonas
and Serratia species infections, resulting in
meningitis from epidural injections (CDC,
unpublished data, 2002; Contra Costa Health
Services, unpublished data, 2002); and
Burkholderia cepacia blood stream infections
from intravenous flush (CDC, unpublished data,
2004). Regulatory oversight of compounding
pharmacies varies among states. However,
compounding pharmacies are subject to
inspection by pharmacy boards, FDA, and
accreditation organizations. The American
Society of Health-System Pharmacists and the
U.S. Pharmacopeia have developed guidance
and standards that address quality assurance and
sterile preparation of compounded products (5,6).
In addition, in May 2004, the Pharmacy
Compounding Accreditation Board (PCAB)
established a task force to set standards for a
voluntary accreditation board for compounding
pharmacies (7).

Companies that manufacture products intended
for injection should follow FDA regulations for
ensuring the sterility of these products (3).
Health-care providers who detect cases of
Pseudomonas species infection in patients with
central venous catheters are urged to determine
whether their patients received the heparin/saline
flush recalled by IV Flush. Although the product
has been recalled, cases have occurred up to 1
month after receipt of the product. Indwelling,
intravenous catheters that are used infrequently
can become colonized with organisms in a
biofilm, and symptoms might not develop until
the catheter is used. Susceptibility patterns of
organisms isolated from the 36 identified patients
have varied, with multiple isolates resistant to
third-generation cephalosporins and carbapenem
antibiotics. Treatment for potential patients
should include targeted antimicrobial therapy
and consideration of removing their catheters (8).
In addition, cases that might be related to use of
this product should be reported to state and local
health departments, CDC, and the FDA
MedWatch program
(http://www.fda.gov/medwatch/report.htm or
1-800-FDA-1088, press 0).

Acknowledgment

The findings in this report are based, in part, on
contributions by BP Zhu, MD, Missouri State Dept
of Health and Senior Svcs.
References

1. Food and Drug Administration. FDA renews
nationwide alert on IV Flush brand of heparin or
sodium chloride intravenous catheter flushes in
light of new contamination reports. Rockville,
MD: US Department of Health and Human
Services, Food and Drug Administration; 2005.
Available at
http://www.fda.gov/bbs/topics/news/2005/new0115
4.html.
2. K Todar. Todar's online textbook of
bacteriology nutrition and growth of bacteria.
Madison, WI: University of Wisconsin-Madison
Department of Bacteriology; 2004. Available at
http://textbookofbacteriology.net/nutgro.html.
3. Food and Drug Administration. Current good
manufacturing practice for finished
pharmaceuticals. Rockville, MD: US Department
of Health and Human Services, Food and Drug
Administration; 1996. Available at
http://www.fda.gov/cder/dmpq/cgmpregs.htm.
4. CDC. Exophiala infection from contaminated
injectable steroids prepared by a compounding
pharmacy. MMWR 2002;51:1109--12.
5. American Society of Health-System
Pharmacists. ASHP technical assistance bulletin
on quality assurance for pharmacy-prepared
sterile products. Am J Hosp Pharm
1993;50:2286--98.
6. U.S. Pharmacopeial Convention, Inc. U.S.
pharmacopeia 28 [Chapter 797]. Pharmaceutical
compounding: sterile preparations. Rockville,
MD: U.S. Pharmacopeial Convention, Inc.;
2004:2461--77.
7. International Academy of Compounding
Pharmacists. Pharmacy compounding
accreditation board appoints standards task force.
Sugar Land, TX: International Academy of
Compounding Pharmacists; 2004. Available at
http://www.iacprx.org/press_releases/05-14-04.htm
.
8. Mermel LA, Farr BM, Sherertz RJ, et al;
Infectious Diseases Society of America;
American College of Critical Care Medicine;
Society for Healthcare Epidemiology of America.
Guidelines for the management of intravascular
catheter-related infections. Clin Infect Dis
2001;32:1249--72.