FDA Adverse Event
Malfunction
Summary report: N
PLUM XLM PUMP
MDR report key: 1170269
·
Received September 11, 2008
Report
- Report Number
- 2921482-2008-00281
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 18, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K953660
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY, THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION IN LOW VOLUME SETTING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM XLM PUMP | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |