FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II ST 400-2-S
MDR report key: 2962073
·
Received January 18, 2013
Report
- Report Number
- 3009089744-2013-00001
- Event Type
- Malfunction
- Date Received
- January 18, 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)(46)): STOP INFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27994 | EASYPUMP II ST 400-2-S | ELASTOMERIC INFUSION PUMP | MEB | B. BRAUN MEDICAL PRODUCTION LTD. | NA | 2D0728EA21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |