FDA Adverse Event
Malfunction
Summary report: N
STOCKERT CAPS ROLLER PUMP
MDR report key: 1201393
·
Received June 27, 2008
Report
- Report Number
- 1718850-2008-00014
- Event Type
- Malfunction
- Date Received
- June 27, 2008
- Manufacturer
- SORIN GROUP DEUTSCHLAND
- Product Code
- DWB
- PMA / PMN Number
- K890904
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE STOCKERT CAPS ROLLER PUMP IS MFG BY SORIN GROUP AND DISTRIBUTED BY SORIN GROUP USA, INC. THE MEDWATCH REPORT STATED THAT THE PUMP WAS PLACED OUT OF SVC PENDING REPAIR. SORIN GROUP USA, INC. SEARCHED THE RECORDS AND FOUND NO EVIDENCE THAT THE PUMP WAS PLACED BACK INTO SVC BY AN SGUSA REP. THE FACILITY HAS NOT RETURNED THE PUMP FOR EVAL. THE RISK MGMT REP WAS CONTACTED AND WAS ASKED TO PROVIDE INFO REGARDING THE STATUS OF THE PUMP. TO DATE, NO INFO HAS BEEN PROVIDED. IF THE PRODUCT IS RETURNED OR ADDITIONAL INFO IS PROVIDED FROM THE FACILITY. A FOLLOW-UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STOCKERT CAPS ROLLER PUMP | PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE | DWB | SORIN GROUP DEUTSCHLAND | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |