FDA Adverse Event
Injury
Summary report: N
SIGMA SPECTRUM INFUSION PUMP
MDR report key: 2232400
·
Received August 31, 2011
Report
- Report Number
- 1314492-2011-00034
- Event Type
- Injury
- Date Received
- August 31, 2011
- Date of Event
- July 10, 2011
- Report Date
- July 18, 2011
- Manufacturer
- SIGMA LLC
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP WAS TESTED FOR FLOW RATE AND THE RESULTS WERE FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP FREE FLOWED INSULIN. INSULIN GTT WAS HUNG AND PLACED ON A SPECTRUM PUMP. THE PUMP ALARMED A COUPLE OF MINUTES LATER WHILE THE NURSE WAS STILL IN THE ROOM. THE ALARM WAS SILENCED AND RUN WAS PRESSED. THE PUMP ALARMED AGAIN AND WAS UNABLE TO BE RUN WITH A "NO TUBING LOADED" MESSAGE. IT WAS REPORTED THAT TUBING WAS LOADED IN PUMP. THE INSULIN BAG WAS NOTED TO BE HALF FULL. THE TUBING WAS IMMEDIATELY REMOVED FROM IV PUMP AND THEN DISCONNECTED FROM THE PATIENT. THE PHYSICIAN WAS NOTIFIED REGARDING THIS EVENT AT 1200 HOURS AND MEDICATION WAS GIVEN PER HIS DIRECTIONS. (ONE AMP D50, IV FLUIDS CHANGED TO DN NS AT 125ML/HR.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | SIGMA LLC | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |