FDA Adverse Event
Malfunction
Summary report: N
PERFUSOR SPACE
MDR report key: 2944102
·
Received January 29, 2013
Report
- Report Number
- 9610825-2013-00002
- Event Type
- Malfunction
- Date Received
- January 29, 2013
- Date of Event
- December 28, 2013
- Report Date
- January 2, 2013
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K062699
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RETURNED HOWEVER, THE LOG HISTORY FILES WILL BE SENT FOR EVALUATION, AT THIS TIME, THE LOG HISTORY FILES FOR THE DEVICE HAVE NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE LOG REVIEW.
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): HYPOGLYCEMIC EVENT: ON (B)(6), A PT AT (B)(6) WAS UNDERGOING INSULIN THERAPY USING SGS AND EXPERIENCED A HYPOGLYCEMIC EPISODE. CUSTOMER NOTIFIED B BRAUN ON (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39468 | PERFUSOR SPACE | INFUSION SYRINGE PUMP | FRN | B. BRAUN MELSUNGEN AG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |