FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3250778
·
Received May 30, 2013
Report
- Report Number
- 3250778
- Event Type
- Malfunction
- Date Received
- May 30, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 30, 2013
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE B. BRAUN SYRINGE PUMP DEVICE FAILURE ALARM CODE WAS HEARD BY THE NURSE WHILE A MEDICATION WAS BEING ADMINISTERED. THE CODE WAS "CODE 1222". APPROXIMATELY 5 MINUTES LATER A SECOND PUMP ADMINISTERING MAINTENANCE FLUID FAILED AND ALARMED WITH THE SAME CODE ("1222"). PUMPS WERE SUBSEQUENTLY CHANGED OUT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEDICATION AND FLUID ADMINISTRATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239809 | * | PUMP | FRN | B. BRAUN MEDICAL INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |