FDA Adverse Event
Malfunction
Summary report: N
VISTA BASIC - IFVB
MDR report key: 3897070
·
Received June 13, 2014
Report
- Report Number
- 2523676-2014-00239
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 9, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: EVENT #1: CUSTOMER OVER REPORTED; THE NURSE HAD 2 INCIDENCES OF OVER INFUSION ON THIS PUMP 1 WAS AN INFUSION OF GAMUMIX EXPECTED TO RUN OVER 3 AND 1/2 HOURS, 1 AND 1/2 HOURS INTO THE INFUSION MORE THAN 1/2 OF THE BAG HAD INFUSED. IN ANOTHER INCIDENT, SET MONOCLONAL ANTIBODIES TO RUN OVER 60 MINUTES BUT IT COMPLETED IN 30 MINUTES. CUSTOMER REPORTS USE SET (B)(4) WHICH IS COMPATIBLE TO THE VISTA PUMP. NO PT INJURY IN EITHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351234 | VISTA BASIC - IFVB | INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |