FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ
MDR report key: 1187777
·
Received September 30, 2008
Report
- Report Number
- 1187777
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- September 12, 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 NITROGLYCERIN AT 11:22AM. AT APPROXIMATELY 11:33 THE PUMP ALARMED WITH MALFUNCTION ALARM S321 MOTOR ERROR, SUBGROUP 9, MALFUNCTION CODE: PUMP BOLUS OVERSHOOT, URGENCY HIGH, ALARM ID: 109, GENERIC ARG 1: 814, ARG 2: 0 ARG 3: 0 ARG 4: 0. THE ALARM WAS ACKNOWLEDGED AND THE CASSETTE HAD TO BE MANUALLY EJECTED. THE INFUSION WAS STOPPED AND THE PUMP POWERED DOWN. I HAVE REGISTERED THIS 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 | * |