CareFusion’s 303 Alaris Pump Module Recalled

The FDA issued a class 1 recall of CareFusion’s 303 Alaris Pump Module, Model 8100 to a large list of recently recalled CareFusion products.

The FDA’s announcement stated “potential for the pump module door keypad overlay to become loose, peel away or separate from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.”

“The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns,” according to the FDA news release.

Starting on July 20, 2102, each affected customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation.

A listing of affected serial numbers are available on the company Web site.

CareFusion will follow-up within 60 days of receiving the letter with a telephone call to schedule a visit to replace the door assembly on their affected pump module.

Earlier this month the FDA announced a class 1 recall of another CareFusion pump, the Alaris PC Unit, Model 8015, part of the Alaris electronic infusion pump, citing a malfunction in its power supply board.

In June, the company issued an update reminding healthcare providers of its class 1 voluntary recall of its AirLife Infant Breathing Circuit, initiated in May.

In addition, in February 2012, the FDA initiated a class 1 recall for a CareFusion brain mapping device because of software malfunctions and a short circuit that can lead to tissue resection errors in patients undergoing surgery for seizures or tumors.

the agency warned that the device’s NicoletOne software with cortical stimulator license incorrectly indicates that stimulation is delivered to a different electrode than the one selected.

It also warned that a short circuit may develop between the Nicolet cortical stimulator control unit and the Nicolet C64 stimulus switching unit amplifier.

In December 2011, the FDA also announced a class 1 recall of CareFusion AVEA ventilators. The affected ventilators may develop a failure mode over a period of time, where the ventilator activates a false “extended high peak” (peak cycling respiratory pressure) alarm, opens the safety valve (by design), and stops ventilating.

You May Also Like


  • This field is for validation purposes and should be left unchanged.


No comments yet.

Leave a Reply

  • This field is for validation purposes and should be left unchanged.
Latest Drug Injury News

Big Pharma under Fire for Kickbacks to Docs

Trust and honesty are the cornerstones to a doctor-patient relationship. With so many doctors receiving financial incentives to use certain medications or medical devices, patients need to know if money drives the decision making process. Doctors are required to disclose potential financial conflicts to each other at conferences, but there currently is no law forcing […]

Dietary Supplements Damage Liver

A recent study revealed a significant increase in liver damage related to dietary supplements. The study, conducted by a national network of liver specialists, found a 13% increase in serious liver damage over a 10 year span. Some of these patients required liver transplants and some have even died due to liver failure. Authors of […]

FDA Advisory Committee Supports Approval of Gilead’s HIV Reducing Drug

The pharmaceutical industry may be on the verge of one of the greatest breakthrough’s that this generation has ever seen.

U.S. Health Regulators Issue New Restrictions For Gilenya, Novartis AG’s’ Multiple Sclerosis Pill

In December 2011, the FDA issued a Drug Safety Communication concerning a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Plavix Linked with Internal Bleeding

Ten more people have died from Plavix, which had proven to be no better than aspirin against stroke even though it costs around 100 times more.

Latest Medical Device Injury News

Report Raises Concerns Over Heart Defibrillator Leads

The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.

HeartSine Class 1 Defibrillator Recall

HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.

FDA Medical Device Approval Based On Little Evidence

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.

St. Jude Medical Gets FDA Warning

St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.

Hospira Still Facing Manufacturing And Regulatory Issues

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.