FDA Adverse Event
Malfunction
Summary report: N
PERFUSOR®
MDR report key: 24084147
·
Received January 15, 2026
Report
- Report Number
- 9610825-2026-00003
- Event Type
- Malfunction
- Date Received
- January 15, 2026
- Report Date
- January 15, 2026
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- MEA
- UDI-DI
- 04046963915308
- PMA / PMN Number
- K092313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
Description of Event or Problem · 0
AS REPORTED BY THE USER FACILITY: PATIENT (CMO) GOT A NEW SYRINGE (15ML) FENTANYL INITIATED AT SHIFT CHANGE (1914). MED CONCENTRATION WAS 50MCG/1ML. RATE 75MCG PER HOUR. SYRINGE SHOULD HAVE BEEN EMPTY AT 0514 (10 HOURS). WHEN RN WENT IN AT 5AM TO CHANGE SYRINGE, THE MACHINE SAID VTBI WAS 0.76, WHICH WOULD MATCH UP WITH RATE/TIMING. HOWEVER, WHEN SYRINGE WAS CHANGED, THERE WAS STILL >5ML IN SYRINGE TO WASTE. WHEN SYRINGE WAS CHANGED AT SHIFT CHANGE, THERE WAS NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146915 | PERFUSOR® | PUMP, INFUSION, PCA | MEA | B. BRAUN MELSUNGEN AG | 97042003K2 | 04046963915308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |