Class 1 Recall: Cardinal Health Alaris® Infusion Pump Module (formerly Medley™ Pump Module), Model 8100

October 29, 2007

Cardinal Health Alaris® Infusion Pump module (formerly Medley^TM Pump module), Model 8100

All Alaris® Infusion Pump modules shipped prior to September 27, 2007 are subject to this recall.

A list of serial numbers for Alaris® Infusion Pumps affected by this recall are available at the firm's website at:
http://www.cardinal.com/alaris/brochure/ Serial_Number_Ranges_affected_by_the_recall.pdf

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

During the manufacturing or servicing of the mechanism assembly, the occluder springs were misassembled (overlapping [nested], missing, bent or broken). If a spring is misassembled, there is a potential for inaccurate flow rate which may lead to a patient’s harm due to over-infusion.

On November 5, 2007, the company sent out a recall notice to their customers.  This recall notice contained "Service Bulletin 528," which described an interim test to verify that the device is operating correctly. Specifically, this test determines the presence of the device’s occluder springs, which are used by the device to control the flow of medication.

On December 20, 2007, the company issued a press release about this recall. The company had revised the original service bulletin because customers complained that the test could not consistently verify the presence of the occluder springs within a device. The company issued a new “service bulletin 528A” to their customers.

For more information about this recall, please see the company’s press release at:  
http://www.cardinal.com/content/news/12202007_154543.asp.

For a copy of the revised Service Bulletin 528A, please see company’s website at:
http://www.cardinal.com/alaris/brochure/PumpModuleRecallServiceBulletin.pdf.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178