Published Date: 2005-03-20 23:50:00
Subject: PRO/EDR> Serratia marcesens, contaminated solution - USA (NJ): alert
Archive Number: 20050320.0808
SERRATIA MARCESENS, CONTAMINATED SOLUTION - USA (NEW JERSEY):ALERT
A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases
Date: Sat, 19 Mar 2005
From: ProMED-mail <firstname.lastname@example.org>
Source: Kansas City Star [edited]
FDA alerts hospitals not to use possibly contaminated IV solution
Federal regulators alerted hospitals nationwide Friday night, 18 Mar 2005,
not to use a solution commonly used on heart patients, saying it may be
contaminated with the bacteria that caused 2005's shortage of flu vaccine.
The FDA issued the alert against use of a PharMEDium Services Magnesium
Sulfate with the lot number 100504900049 and expiration date 4/4/05. It is
produced by PharMEDium Services of Houston. The product is often given
intravenously to patients undergoing cardiac surgery and was apparently
distributed to several hospitals around the country.
So far it has been associated with at least 5 recent cases of _Serratia
marcescens_ infection in a hospital in New Jersey, the FDA said, without
identifying the hospital. All patients have responded to treatment with
antimicrobial agents and are reportedly recovering well, the agency said.
"This product ... may be contaminated with _Serratia marcescens_ bacteria
that can cause serious, life-threatening illness in patients with
compromised immune systems," it said in a statement. The FDA, CDC and other
public health authorities are investigating to determine if other lots of
this product may be affected.
_Serratia marcescens_ bacteria is a common contaminant in labs and is the
germ officials said tainted the flu vaccine at a British factory. It is
blamed for urinary tract infections, infected surgical wounds and
pneumonia, usually spread among hospital patients.
Date: Fri, 18 Mar 2005
From: ProMED-mail <email@example.com>
Source: Food & Drug Administration [edited]
FDA Issues Nationwide Alert on lot of magnesium sulfate solution
FDA is issuing a nationwide alert against the use of PharMEDium Services
Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot
number 100504900049 and expiration date 4/4/05. This product is
manufactured by PharMEDium Services of Houston, Texas and may be
contaminated with _Serratia marcescens_ bacteria that can cause serious,
life-threatening illness in patients with compromised immune systems.
This product is frequently administered intravenously to patients
undergoing cardiac surgery and was apparently distributed to several
hospitals around the country. To date it has been associated with at least
5 recent cases of _Serratia marcescens_ infection in a hospital in New
Jersey. All patients have responded to treatment and are reportedly
The firm has notified FDA that it is in the process of withdrawing this lot
from hospitals. FDA, the CDC, and other public health authorities are
investigating this problem to determine if other lots of this product may
be affected. More information will be provided as the investigation develops.
Hospitals with questions may contact the company at 1-847-457-2300. Persons
wanting to report anything to the Food and Drug Administration regarding
this products may contact FDA's MedWatch office at 1 800-FDA-1088.
[_Serratia marcescens_ can cause a wide variety of hospital-acquired
infections and has been associated with infections in injecting drug users,
particularly endocarditis and osteomyelitis. Immunologically normal
individuals can acquire _S. marcescens_ infection especially in the
hospital setting. The organism is widespread in the environment but not a
common component of the human fecal flora.
Environmental and even some clinical strains of _S. marcescens_ can produce
a red pigment called prodigiosin. Bartolemeo Bizio, first described the
organism in 1819 as the cause of red discoloration of polenta (a dish made
from corn meal), which discredited the claim that the color was due to the
miraculous appearance of blood. He gave the organism its genus name to
honor Serafino Serrati, whom he felt had not received proper credit for
invention of the steamboat, and its species name for the Latin word for "to
decay," because of the tendency of the pigment to change color as the
colonies age. Serial passage may also cause the organism to lose its
pigment producing ability.
The production of the pigment together with the belief that the bacterium
was nonpathogenic, led to its use as a biologic marker to study, among
other things, transmission of bacteria through speech and contact,
ascending colonization of the bladder in patients with urinary catheters,
and the dissemination of aerosolized bacteria after experimental release in
models of biologic warfare. - Mod. LL]
[At the risk of being overly provocative, it is curious that this is the
second episode of post-cardiac sepsis being reported in the past 2
weeks. The prior episode was a single case report of _Burkholderia
cepacia_ (see reference below) occurring within 12 hours following cardiac
surgery. While the organisms are not related, one does start wondering
about possible additional contaminations that may have occurred. - Mod.MPP]