FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ TRIPLE NEW 8
MDR report key: 2193530
·
Received July 21, 2011
Report
- Report Number
- 9615050-2011-00547
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE CHANNEL 1 OF THE PUMP DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+ TRIPLE NEW 8 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |