FDA Adverse Event
Malfunction
Summary report: N
PLUM XLMD PUMP
MDR report key: 1061943
·
Received June 16, 2008
Report
- Report Number
- 2921482-2008-00192
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- May 30, 2008
- Report Date
- June 2, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K010924
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
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 INTERMITTENTLY DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE IN THE 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 XLMD PUMP | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |