FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ
MDR report key: 1187770
·
Received September 30, 2008
Report
- Report Number
- 1187770
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 30, 2008
- Manufacturer
- HOSPIRA GLOBAL MEDICAL AFFAIRS
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
Narratives
Description of Event or Problem · 1
THE SYMBIQ PUMP BEGAN INFUSING AT 1:08:59. AT APPROXIMATELY 21:09:43 THE PUMP ALARMED WITH MALFUNCTION ALARM S421 MOTOR ERROR, SUBGROUP 19, CODE: PUMP INCREMENTAL BOLUS UNDERSHOOT. URGENCY HIGH, ALARM ID 132, GENERIC ARG 1: 4163, ARG 2: 0 ARG 3:0, ARG 4: 0. THE ALARM WAS ACKNOWLEDGED AND THE CASSETTE WAS EVENTUALLY EJECTED. THE INFUSION WAS STOPPED AND THE PUMP POWERED DOWN. I HAVE REGISTERED THIS PROBLEM WITH THE OEM AND HAVE RETURNED IT FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMBIQ | PUMP, IV | FRN | HOSPIRA GLOBAL MEDICAL AFFAIRS | SYMBIQ | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |