FDA Adverse Event
Malfunction
Summary report: N
PLUM XLMD PUMP
MDR report key: 1231145
·
Received October 30, 2008
Report
- Report Number
- 2921482-2008-00349
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 8, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K010924
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 SPARKS. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "CAN SEE SPARKS." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, SPARKING WAS NOTED INTERNAL TO THE PUMP WHERE THE AC CONNECTORS CONNECT TO THE PRINTED CIRCUIT BOARD. 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 | UNK |