FDA Adverse Event
Malfunction
Summary report: N
PLUM XLMD PUMP
MDR report key: 1170771
·
Received September 15, 2008
Report
- Report Number
- 2921482-2008-00292
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 18, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K010924
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE PUMP 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 |