Recall Z-2447-2024 ยท FRN Pump, Infusion
ICU Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusin Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser c
| Date | Aug 9, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected. |
| Root cause | Process control |
| Action | Consignees were notified on about 05/07/2024 via traceable mail with an "UPDATED URGENT MEDICAL DEVICE CORRECTION" letter to the original recall was expanding. Consignees were instructed to replace batteries the first time the pump issues a replace battery alarm. Continued use of pumps on battery after the first instance of the replace battery alarm will reduce the time from a low battery alarm to a depleted battery/infusion stopping. Additionally, pumps should be kept plugged into AC power, closely monitor if using battery power, have a backup pump available, and do not use a replacement ba |
| Quantity | 11,961 units |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay. |
| FDA record | Open on fda.gov |