FDA Adverse Event
Malfunction
Summary report: N
INFUSOMAT SPACE - US VERSION
MDR report key: 3953526
·
Received July 8, 2014
Report
- Report Number
- 9610825-2014-00267
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K062700
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL DEVICE HAS NOT BEEN REC'D YET AND THE INVESTIGATION IS ONGOING AT THIS TIME. IN A F/U WITH THE FACILITY, THE REPORTER CONFIRMED THERE WAS NO PATIENT INJURY OR CONSEQUENCES TO PATIENT. A F/U REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397427 | INFUSOMAT SPACE - US VERSION | INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |