FDA Adverse Event
Malfunction
Summary report: N
INFUSOMAT SPACE
MDR report key: 4180777
·
Received September 26, 2014
Report
- Report Number
- 9610825-2014-00351
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- September 10, 2014
- Report Date
- September 16, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FPA
- PMA / PMN Number
- K062700
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN REQUESTED TO BE SENT TO BBM (B)(4) FOR EVAL. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS BECOME AVAILABLE. (B)(4).
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): OVER INFUSION: PUMP INFUSED MORE THAN PROGRAMMED. PTS HEALTH WAS NOT COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 599927 | INFUSOMAT SPACE | INFUSION PUMP | FPA | B. BRAUN MELSUNGEN AG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |