FDA Adverse Event
Malfunction
Summary report: N
PLMA DVC V11. 51 1 N
MDR report key: 1883135
·
Received October 19, 2010
Report
- Report Number
- 2921482-2010-00797
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 20, 2010
- Report Date
- September 21, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE PUMP COULD BE PROGRAMMED WHEN THE LOCKOUT SWITCH WAS PLACED IN THE LOCKED POSITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLMA DVC V11. 51 1 N | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE: LIST #12097 (B)(4) |