Recall Z-0207-2014 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
| Date | Nov 14, 2013 (initiated Feb 5, 2012) |
| Status | Terminated |
| Reason | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not |
| Root cause | Nonconforming Material/Component |
| Action | Hospira sent an URGENT DEVICE FIELD CORRECTION letter dated February 5, 2013 was sent to all direct accounts notifying them of the issue. For device users who experience these issues, Hospira recommends the following actions be taken: 1) Remove the pump from service and perform a Performance Verification Test (PVT) Distal Occlusion Test to determine if the distal pressure sensor is performing correctly. 2) If the device does not pass the PVT, it may indicate that the distal pressure sensor has drifted. Perform the appropraite troubleshooting and repair activities defined by the user's faci |
| Quantity | List No. 12391: 182,970 units |
| Distribution | Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc., Apr 24, 2007 |