FDA Adverse Event
Malfunction
Summary report: N
SIGMA SPECTRUM INFUSION PUMP
MDR report key: 2212805
·
Received July 20, 2011
Report
- Report Number
- 1314492-2011-00032
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 22, 2011
- Manufacturer
- SIGMA LLC
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SIGMA CONFIRMED THE COMPLAINT ON 06/21/2011 DURING A PRELIMINARY INVESTIGATION. INVESTIGATION IS STILL IN PROGRESS AND A SUPPLEMENTAL WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE FACILITY THAT THE PUMP FAILED OCCLUSION PRESSURE TEST FOUND DURING A ROUTINE SECONDARY INSPECTION TEST. OCCLUSION ALARM OCCURRED AT 22 PSI WHEN IT WAS REQUIRED TO OCCUR AT 13 +/-6 PSI. IT WAS ALSO REPORTED THAT THE PUMP FAILED FLOW RATE TEST BY 10 PERCENT. THE PUMP DELIVERED 180 ML WHEN TESTED AT 200 ML/HR WITH A VTBI OF 200 ML/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 |