HEATER-COOLER SYSTEM 3T
Report
- Report Number
- 9611109-2022-00075
- Event Type
- Malfunction
- Date Received
- February 22, 2022
- Date of Event
- January 25, 2022
- Report Date
- February 22, 2022
- Manufacturer
- LIVANOVA DEUTSCHLAND
- Product Code
- DWC
- UDI-DI
- 04033817901099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND FOUND NO ERROR ON THE STIRRER MOTOR. HOWEVER, HE FOUND THAT THE PATIENT PUMP 1 WAS STUCK. THE PUMP WAS REPLACED AS WELL AS THE DISTRIBUTION BOARD AND ISSUE COULD BE SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND FOUND NO ERROR ON THE STIRRER MOTOR. HOWEVER, HE FOUND THAT THE PATIENT PUMP 1 WAS STUCK. THE PUMP WAS REPLACED AS WELL AS THE DISTRIBUTION BOARD AND ISSUE COULD BE SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
H.10: IN THE INITIAL REPORT IT WAS STATED THAT: "A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND FOUND NO ERROR ON THE STIRRER MOTOR. HOWEVER, HE FOUND THAT THE PATIENT PUMP 1 WAS STUCK. THE PUMP WAS REPLACED AS WELL AS THE DISTRIBUTION BOARD AND ISSUE COULD BE SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. " THROUGH FOLLOW UP COMMUNICATION LIVANOVA LEARNED THAT THE ABOVE ACTIVITY WAS REPORTED INCORRECTLY. PLEASE CONSIDER VALID THE STATEMENT BELOW: "A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND FOUND NO ERROR ON THE STIRRER MOTOR. HOWEVER, HE FOUND THAT THE PATIENT PUMP 1 WAS STUCK. THE PUMP COULD BE ROTATED ONCE PUSHED BY HAND THUS IT WAS NOT REPLACED AND THE ISSUE COULD BE SOLVED. THE DISTRIBUTION BOARD WAS CHANGED WITH ANOTHER. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE." IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
H.10: THE MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE IS ASSOCIATED TO MOTOR BEARING CORROSION, WHICH CONSEQUENTLY DOES NOT ALLOW THE MOTOR SHAFT TO ROTATE FREELY. POSSIBLE CAUSES ARE WATER INFILTRATION OR WATER FORMATION DUE TO CONDENSATION OR HIGH TEMPERATURES AND HIGH LEVEL OF HUMIDITY IN THE STATIONARY PHASE. CAUSES RELATED TO ENVIRONMENTAL CONDITIONS.
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO THE STIRRER MOTOR ON THE PATIENT CIRCUIT DURING PRIMING.THERE WAS NO PATIENT INVOLVEMENT.
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO THE STIRRER MOTOR ON THE PATIENT CIRCUIT DURING PRIMING.THERE WAS NO PATIENT INVOLVEMENT.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1005761 | HEATER-COOLER SYSTEM 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND | 16-02-80 | 04033817901099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |