Cardinal Health Posts Safety Alert For Infusion Product
March 11 2009 - 2:34PM
Dow Jones News
Cardinal Health Inc. (CAH) has issued an urgent safety alert
warning of a potential risk for improper dosing of medication with
one of its infusion modules.
The voluntary alert, dated Tuesday, marks another glitch for the
medical supply company's line of Alaris products, some of which
have undergone recalls and prompted government action in recent
years. It comes three weeks after Cardinal said it reached an
agreement with the U.S. Food and Drug Administration to conduct a
thorough review of its broad line of infusion pump products, based
on an FDA finding that certain pumps do not meet safety standards
of the Federal Food, Drug and Cosmetic Act.
Cardinal identified the potential risk after investigating two
inquiries on the issue from customers, spokesman Troy Kirkpatrick
said Wednesday. The company expects to include the planned software
update to fix the problem in a larger corrective action plan due in
late April under its recently amended agreement with the FDA
covering the company's infusion pump products, he said.
Cardinal shares recently traded down $3.00, or 9.46%, at
$28.70.
The new safety alert notification, posted on Cardinal's Web
site, informs of a potential risk when the Alaris PCA (patient
controlled analgesia) module, model 8120, is used with the Alaris
PC unit, models 8000 and 8015, with software versions 8 through
9.1.
"The Alaris PCA module can potentially infuse above or below the
intended infusion dose" when all of five specific events occur,
including use of an optional therapy feature in the software and a
clinician's ignoring warnings on the display, the company said.
No death has resulted from this potential risk, according to
Cardinal's Web site. Cardinal detailed actions required for users
of the Alaris PCA module and the Alaris PC unit.
Cardinal, a major drug wholesaler and medical supplier, is
sending a letter to each affected Alaris customer, distributor and
third-party service provider, and offering a support center and
instructions for addressing the potential risk.
Cardinal infusion pumps other than the Alaris PC unit and Alaris
PCA module are not affected by the safety alert, the company said.
Products not covered by the new alert include the Alaris SE pump,
Alaris pump module, Gemini infusion pump, Alaris syringe module and
MedSystem III pump, the company said.
Cardinal last month said it had reached an agreement with the
FDA on an amended consent decree regarding its infusion pump
products. The company has operated under the decree since February
2007 for its Alaris SE pumps.
Under the amended agreement, Cardinal said it would conduct a
thorough review of its broader line of infusion pump products and
submit a corrective action plan to the FDA that outlines all
planned modifications to infusion pump products.
The FDA alleges in the amended consent decree that a January
2008 inspection showed certain Cardinal infusion pumps do not meet
federal safety standards, according to Cardinal. The amended
agreement, however, doesn't affect Cardinal's ability to sell its
infusion pump products, other than the Alaris SE pump.
In 2006, Cardinal recalled its Alaris SE infusion pumps, which
were designed to give controlled amounts of medications or other
fluids to patients intravenously, because of a defect in some pump
keypads that could cause overinfusion. The keypads sometimes
registered numbers twice when pressed only once. The FDA seized
problematic Alaris SE pumps at the company's facility and, at the
time, noted that overinfusion could potentially cause serious harm
or death in a patient. Cardinal suspended production of the Alaris
SE pumps.
Separately, in 2007, Cardinal voluntarily recalled its Alaris
pump modules shipped before Sept. 27 that year, citing a potential
for an inaccurate flow rate that could cause a patient to receive
too much intravenous medication.
-By Dinah Wisenberg Brin, Dow Jones Newswires; 215-656-8285;
dinah.brin@dowjones.com