BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
- Company
- Carefusion 303, Inc.
- Recall Initiated
- August 4, 2020
- Recall Number
- Z-2939-2020
- Quantity
- 248,519
- Firm Location
- San Diego, CA
Reason for Recall
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Distribution
Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary (HU); Israel (IL); Japan (JP)* Kuwait (KW); New Zealand (NZ); Philippines (PH); Qatar (QA); Saudi Arabia (SA); Singapore (SG); Taiwan (TW); Turkey (TR)*. *There are 159 U.S. government and/or military consignees including two located in Japan (JP) and Turkey (TR).
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
On August 4, 2020, the firm notified affected customers via mail, "Urgent Medical Device Recall", indicating the following: Actions for Clinical Users: Clinicians should remove the pump from service and send to Biomedical Engineering if the Pump Module keypad becomes unresponsive or stuck. If a critical medication is being administered, continue the infusion until it is safe to replace the Pump Module. In an urgent situation, clinicians can close the roller clamp on the IV administration set to stop an infusion. Actions for Cleaning Personnel: Follow the cleaning instructions provided in the current Directions for Use to minimize the potential for fluid ingress during cleaning. - Do not use a cloth that drips. Be sure to wring out the cleaning cloth to squeeze out excess fluid. - Do not spray fluids directly onto the device. Actions for Biomedical Engineering: Inspect all uninstalled Pump Module Door Assembly Replacement Kits noted above. All kits dated prior to January 25, 2019 are affected. If affected kits are found upon inspection, dispose per facility guidelines. An example of how to identify the date on the keypad is provided below: - Contact BD at 1-800-482-4822 to order replacement Pump Module keypad kits at no charge (either discarded by your facility or needed for remediation of the Pump Module), - Contact the BD Recall Support Center at 1-888-562-6018 to schedule remediation of the pump module at no charge if unable to perform at your location. - Maintain a list of all Pump Module serial numbers remediated to provide to BD upon completion of the activity. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and the recall instructions provided in this letter. Actions for BD Alaris System rental providers: Provide a copy of this letter to your customers who are currently renting BD Alaris System devices. Actions by BD: BD redesigned and implemented the Alaris Pump Mo