FDA Adverse Event
Malfunction
Summary report: N
INFUSOMAT SPACE PUMP
MDR report key: 2932143
·
Received January 19, 2013
Report
- Report Number
- MW5028711
- Event Type
- Malfunction
- Date Received
- January 19, 2013
- Date of Event
- December 15, 2012
- Report Date
- January 19, 2013
- Manufacturer
- BRAUN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
POSSIBLE PUMP ERROR/MALFUNCTION. HEPARIN DRIP STARTED AT 0000 (B)(6). VERIFIED BY 2 RN'S. RN NOTED ONLY 25 TO 50 CC REMAINING IN BAG AT 0600. MD NOTIFIED. HEPARIN DRIP DC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28595 | INFUSOMAT SPACE PUMP | INFUSOMAT SPACE PUMP | FRN | BRAUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |