FDA Adverse Event
Other
Summary report: N
S5 MAST ROLLER PUMP
MDR report key: 2912944
·
Received December 21, 2012
Report
- Report Number
- 1718850-2012-01108
- Event Type
- Other
- Date Received
- December 21, 2012
- Report Date
- December 4, 2012
- Manufacturer
- SORIN GROUP DEUTSCHLAND
- Product Code
- DTQ
- PMA / PMN Number
- K062396
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SORIN GROUP (B)(4) MANUFACTURES THE S5 MAST ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED OUT ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
SORIN GROUP RECEIVED A REPORT THAT DURING SETUP, THE S5 MAST ROLLER PUMP STOPPED AND THE DISPLAY FAILED. NOISE WAS ALSO OBSERVED COMING FROM THE PUMP. NO ERROR MESSAGES WERE DISPLAYED. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S5 MAST ROLLER PUMP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | SORIN GROUP DEUTSCHLAND | 10/88-0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |