FDA Adverse Event
Malfunction
Summary report: N
PLUM XLM PUMP
MDR report key: 1032903
·
Received April 23, 2008
Report
- Report Number
- 2921482-2008-00132
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- April 4, 2008
- Report Date
- April 4, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K953660
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO 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 |