FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II ST 100-0, 5-S
MDR report key: 3050608
·
Received March 13, 2013
Report
- Report Number
- 3009089744-2013-00054
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 14, 2013
- Report Date
- March 13, 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. BRAUN (B)(4) INTERNAL REPORT #(B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(4) 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 BBM SALES ORGANIZATION IN (B)(4)): SLOW FLOW. INFUSION TOOK 1 HOUR INSTEAD OF 30 MINUTES. DRUG: CETOFAXIME 4G.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106588 | EASYPUMP II ST 100-0, 5-S | ELASTOMERIC INFUSION PUMP | MEB | B. BRAUN MEDICAL PRODUCTION LTD. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |