Class I Medical Device Recall: CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12
Recall Class: Class I
Date Recall Initiated: March 6, 2013
Product: Alaris PC Unit (Model 8015) with Software Version 9.12
This product was distributed from Sept. 21, 2012 through March 5, 2013.
Use: The Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion pump delivers controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
3750 Torrey View Court
San Diego, California 92130-2622
Reason for Recall: CareFusion has received reports of a communication error on the Alaris PC unit (model 8015) with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. Use of this product may cause serious adverse health consequences, including death.
Public Contact: For questions about this recall,customers may contact the CareFusion Recall Support Center at 1-888-562-6018, Monday through Friday, 7:00 AM to 4 PM, Pacific Time or by email at SupportCenter@carefusion.com.
For technical questions regarding the Alaris System, customers may contact CareFusion at 1-888-812-3229, Monday through Friday, 6 AM to 5 PM, Pacific Time or by email at DL-US-INF-TechSupport@carefusion.com.
District Office: Los Angeles District Office
FDA Comments: On March 6, 2013, the firm issued a recall notification letter informing affected customers about a potential risk associated with the Alaris PC Unit (model 8015) with software version 9.12 .
The letter (see under Additional Links below) stated that CareFusion received reports of customers experiencing a communication error on the Alaris PC unit (model 8015) with software 9.12 when attached to the Alaris EtCO2 module (model 8300) or the Alaris SpO2 module (models 8210 and 8220). While toggling between the Alaris EtCO2 Main Screen, displaying the Capnography waveform, and the EtCO2 Limits screen, the Alaris PC unit may experience a communication error. The communication error can also be experienced while toggling between the Alaris SpO2 Main Screen, displaying the Pleth waveform, and the SpO2 Limits screen. The Alaris PC unit will produce an audible alarm and the attached modules will display a Communications Error message with a flashing red light. See the visual alarms on the Alaris PC unit and attached modules in the firm’s FAQs (See under Additional Links below.).
When the Alaris PC unit experiences a communication error, the programmed infusion(s) will continue as programmed. However, no further key presses on the Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device. Powering down of the device results in termination of all infusions. Termination of an infusion could result in serious injury or death.
Required Action for Users:
Either discontinue the use of the EtCO2 or SpO2 module(s) until the correction has been implemented by CareFusion, or weigh the risk/benefit to patients before continuing to use the Alaris EtCO2 module or Alaris SpO2 module(s).
If you experience a communication error on the Alaris PC unit, contact CareFusion Customer Advocacy at 1-888-812-3266, 24 hours a day, 7 days a week or by email at firstname.lastname@example.org.
Customers are required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, self-addressed mail, fax, or email.
Action by CareFusion:
A CareFusion representative will contact all affected customers within 60 days to schedule a software upgrade to correct this issue.
CareFusion does not require customers to return their devices.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.