FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II LT
MDR report key: 2794597
·
Received September 28, 2012
Report
- Report Number
- 9610825-2012-00189
- Event Type
- Malfunction
- Date Received
- September 28, 2012
- Date of Event
- August 23, 2012
- Report Date
- September 28, 2012
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K081905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXEMPTION NUMBER (B)(4). B.BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(6) TO B BRAUN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY B BRAUN (B)(4)): STOP OF THE FLOW. THE 6 CASES WITH DIFFERENT PTS- DRUG: 5FU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYPUMP II LT | ELASTOMERIC INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG | NA | 1M1228EH12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |