FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP II
MDR report key: 3854199
·
Received May 29, 2014
Report
- Report Number
- 2523676-2014-00214
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 5, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
(B)(4). THE EASYPUMP NEEDED MORE THAN A HOUR INSTEAD OF A HALF A HOUR AN WAS STILL NOT EMPTY. INSIDE IS 2 GR CEFTRIAXON. THE NURSE HAS FORCED ONE EP BY HAND TO EMPTY. THIS ONE IS EMPTY. THE OTHER ONE IS THE ONE THAT WAS STILL NOT EMPTY AFTER A HOUR. MFR - 9610825-2014-00214.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316832 | EASYPUMP II | ELASTOMERIC INFUSION PUMP | MEB | B. BRAUN MELSUNGEN AG | NA | 4A3125E381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |