FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II LT 100-50-S
MDR report key: 2962022
·
Received January 18, 2013
Report
- Report Number
- 3009089744-2013-00003
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 18, 2013
- Manufacturer
- B. BRAUN MEDICAL PRODUCTION LTD.
- Product Code
- MEB
- 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
THIS REPORT HAS BEEN IDENTIFIED AS (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(6) 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)(6) SALES ORGANIZATION IN (B)(6)): STOP INFUSION, DOES NOT FLOW, DRUG: 5FU 4G, FILL VOLUME: 96ML, ROOM TEMPERATURE, START DATE AND TIME OF INFUSION: (B)(6) 2013, 12H00, END DATE AND TIME OF INFUSION: (B)(6) 2013, 12H00.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27799 | EASYPUMP II LT 100-50-S | ELASTOMERIC INFUSION PUMP | MEB | B. BRAUN MEDICAL PRODUCTION LTD. | NA | 2C1328EH11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |