FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II LT 100-50-S
MDR report key: 2850291
·
Received October 24, 2012
Report
- Report Number
- 9610825-2012-00217
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 24, 2012
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K081905
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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). THE DEVICE IS CURRENTLY SHIPPING FROM THE CUSTOMER TO BBM IN (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 BBM SALES ORGANIZATION IN (B)(4)): THE PUMP HAS BEEN RUNNING ONLY UP TO HALF. CAUTION, FILLED WITH FLUOROURACIL 3775 MG 75.5 ML (5 FU) AND NAC1 0.9% 20.5 ML. THE PT HAS BEEN NOTICED AT HOME THAT THE PUMP IS NOT RUNNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYPUMP II LT 100-50-S | ELASTOMERIC INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG | NA | 2B2328EH11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |