Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Recall
- Recall Number
- Z-1682-2017
- Event Number
- 76253
- Firm
- Hospira Inc., A Pfizer Company
- FEI Number
- 3013319212
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Software in the Use Environment
- Initiated
- December 30, 2016
- Terminated
- July 9, 2019
- Address
- 275 N Field Dr, Lake Forest, IL, 60045-2579
Description
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
On 12/30/2016, firm sent notification of the recall to Hospira direct consignees of record via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Effectiveness of the communication will be confirmed by phone call with direct consignees who do not respond. The final disposition of the recalled product will be field correction (firm will contact consignees to upgrade the software in their Plum 360 infusion pumps).
Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
62,847 units