FDA Adverse Event
Malfunction
Summary report: N
SIGMA SPECTRUM INFUSION PUMP
MDR report key: 2467402
·
Received February 15, 2012
Report
- Report Number
- 1314492-2012-00024
- Event Type
- Malfunction
- Date Received
- February 15, 2012
- Date of Event
- January 16, 2012
- Report Date
- January 16, 2012
- Manufacturer
- SIGMA LLC
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. FLOW RATE TESTS WERE PERFORMED AND INACCURACIES EXCEEDING +/- 10% WERE RECORDED. FURTHER ENGINEERING EVAL OF THE DEVICE IS REQUIRED AND WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING ACCEPTANCE INSPECTION A PUMP WAS PROGRAMMED TO DELIVER 200ML/HR AND WAS AVERAGING 160ML/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 |