MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-12-06 for PLUM A+ PUMP - MEDNET WIRELESS 20679 manufactured by Hospira, Inc..
[19956543]
The customer contact reported the device powered off by itself while plugged into an ac outlet without sounding an audible alarm tone. At an unspecified time, the device was programmed to deliver a hydration fluid and the delivery was started while the device was plugged into an ac outlet. No specific programming parameters were provided. Approx 1 minute later, the nurse went back into the pt's room and noted the device's display was blank and that the device had powered off by itself. No audible alarm had sounded. The device was removed from clinical svc. Therapy was resumed using a replacement device. There were no reported adverse pt effects. No medical interventions were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921482-2005-00656 |
| MDR Report Key | 650408 |
| Report Source | 05 |
| Date Received | 2005-12-06 |
| Date of Report | 2005-11-16 |
| Date of Event | 2005-11-16 |
| Date Mfgr Received | 2005-11-16 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2005-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN, PH.D.,DIR |
| Manufacturer Street | 8401 W 102ND ST,DEPT.NO.097U BLDG.NO.HW1, STE 300 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPIRA, INC. |
| Manufacturer Street | 755 JARVIS DR. |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUM A+ PUMP - MEDNET WIRELESS |
| Generic Name | INFUSION PUMP |
| Product Code | FRA |
| Date Received | 2005-12-06 |
| Model Number | NA |
| Catalog Number | 20679 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 639874 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | 755 JARVIS DR. MORGAN HILL CA 95037 US |
| Baseline Brand Name | PLUM A+ PUMP-MED NET WIRELESS |
| Baseline Generic Name | INFUSION PUMP |
| Baseline Model No | NA |
| Baseline Catalog No | 20679 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-06 |