FDA Adverse Event
Malfunction
Summary report: N
PERFUSOR SPACE ACM-KIT
MDR report key: 3952593
·
Received July 17, 2014
Report
- Report Number
- 9610825-2014-00280
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K062699
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL DEVICE INVOLVED HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED 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 |
|---|---|---|---|---|---|---|---|
| 420265 | PERFUSOR SPACE ACM-KIT | INFUSION SYRINGE PUMP | FRN | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |