FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1941427
·
Received December 13, 2010
Report
- Report Number
- 1941427
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 23, 2010
- Report Date
- December 13, 2010
- Manufacturer
- COBE
- Product Code
- DWB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
THE PT WAS PLACED ON ECMO (EXTRACORPEAL MEMBRANE OXYGENATION). WITHOUT ANY INDICATION OR ALARM, THE ROLLER HEAD (ECMO PUMP) STOPPED. THE PT WAS IMMEDIATELY CLAMPED OFF ECMO. THE ROLLER HEAD PUMP WAS RESTARTED AND THE PT WAS PLACED BACK ON ECMO. THE PUMP WAS EVENTUALLY REPLACED WITH THE BACK UP ROLLERHEAD. SOMEONE FROM THE COMPANY CAME IN TO LOOK AT THE MACHINE AND IT WAS DETERMINED THAT THE MOTOR CIRCUIT BOARD WAS TO BLAME, NOT THE ROLLERHEAD. ALTHOUGH THE PATIENT EXPIRED, IT HAD NOTHING TO DO WITH THE INCIDENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | ECMO ROLLERHEAD PUMP | DWB | COBE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |