The US Food and Drug Administration reported the following medical device recalls today –
CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its previously disclosed recall of approximately 17,000 Alaris PC units model 8015 manufactured or serviced between December 2008 and September 2009.
The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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On August 24, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Alaris PC unit model 8015 stating that under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down with a delay in therapy, which could lead to a serious injury or death.
In the notification letter, customers were provided clinical tip sheets and informed of warning tags for each of the affected units. Customers were also given instructions on how to temporarily or permanently disable the wireless mode of the PC unit setting to further mitigate the risk. This information is available at: http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx9
CareFusion is conducting a field corrective action to update the hardware on affected PC units.
The company recorded a reserve in its 2010 fiscal fourth quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations. The voluntary recall only affects Alaris PC units model 8015 manufactured or serviced between December 2008 and Sept. 2009 and therefore, has no affect on the company’s current infusion pump production or shipping processes.
Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall, including serial numbers of affected devices, can be found at http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx10
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by Fax at 1-800.FDA.0178 or at www.fda.gov/medwatch11.
WalkMed Infusion LLC, Englewood, Colorado, is initiating a nationwide recall of a total of 2018 Triton Pole Mount Infusion Pumps. The pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.
Consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer.
The recall includes the serial numbers 001 through 500 and serial numbers TR1401 through TR 2559 manufactured and sold before June 2010.
The firm voluntarily recalled the products after learning of the potential that the door open alarm might not function in certain door open positions. FDA has been apprised of this action.
No injuries have been reported to date and no reports of this issue have been received from field use. The issue was found internally by WalkMed Infusion. The condition has been found on some, but not all pumps in these serial number ranges and results from variability in the door open sensor mechanism. If the pump door is not closed and latched per the instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set for flow prior to starting the pump. If the instructions for use on the side of the pump and in the operator manual for set up and tube set placement are followed, gravity feed flow will not occur from this condition.
The Triton Pole Mount Infusion Pump was distributed nationwide to eight customers or distributors.
WalkMed Infusion has notified its distributors and customers by phone and e-mail and has begun the upgrade of all recalled products. Five of these eight distributors and customers have had their pumps upgraded.
Consumers with questions may contact the company at 1-303-420-9569 between the hours of 8:00 AM and 4:00 PM Mountain Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm10. Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20857