S5 ROLLER PUMP
Report
- Report Number
- 9611109-2021-00204
- Event Type
- Malfunction
- Date Received
- April 13, 2021
- Date of Event
- March 18, 2021
- Report Date
- April 13, 2021
- Manufacturer
- LIVANOVA DEUTSCHLAND
- Product Code
- DWB
- PMA / PMN Number
- K071318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE FAILURE WAS TRACED BACK TO A DEFECTIVE MOTOR CONTROL BOARD. THE PART WAS REPLACED AND THE PROBLEM SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.
H10: IN THE INITIAL REPORT THE PRODUCT CODE WAS WRONGLY SET TO DWC. THE CORRECT CODE IS DWB AND HAS BEEN ALIGNED ACCORDINGLY IN D SECTION.
H.10: THE SERIAL READ-OUT OF THE INVOLVED PUMP WAS REQUESTED AND ANALYZED. AN ERROR CODE ASSOCIATE TO A/D CONVERTER FAILURE WAS FOUND STORED. THE AD CONVERTER IS PART OF THE MICRO-CONTROLLER LOCATED ON THE MOTOR CONTROL BOARD WHICH WAS REPLACED.
LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553306 | S5 ROLLER PUMP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DWB | LIVANOVA DEUTSCHLAND | 10-80-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |