FDA Adverse Event
Summary report: N
INFUSOMAT SPACE - US VERSION
MDR report key: 3722013
·
Received February 26, 2014
Report
- Report Number
- 2523676-2014-00029
- Date Received
- February 26, 2014
- Report Date
- February 20, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: THE NURSE PUT PU A 100 ML BAG AT 10 ML/H. AFTER APPROX. 6 HOURS, THE BAG AND TUBING WERE EMPTY UP TO THE PUMP, BUT THE REMAINING VOLUME INDICATED 45 ML REMAINING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117505 | INFUSOMAT SPACE - US VERSION | INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |