HEATER-COOLER SYSTEM 3T
Report
- Report Number
- 9611109-2022-00079
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Report Date
- February 24, 2022
- Manufacturer
- LIVANOVA DEUTSCHLAND
- Product Code
- DWC
- UDI-DI
- 04033817901099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT 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). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT 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). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
CUSTOMER INFORMATION HAS BEEN ADDED TO THE DEDICATED E SECTION. THROUGH FOLLOW UP COMMUNICATIONS LIVANOVA BECAME AWARE OF DEVICE MODEL/SERIAL NUMBERS WHICH HAVE BEEN ADDED TO THE DEDICATED D.4 SECTION. THE DEVICE MANUFACTURING DATE HAS BEEN ADDED ACCORDINGLY TO H.4 SECTION. H.10: THROUGH A FOLLOW UP COMMUNICATION IT WAS LEARNT THAT THE STIRRER MOTOR IN PATIENT BRIDGE STOPPED DURING PRIMING AND THAT NO ERROR CODE WAS NOTICED BY THE USER. IT WAS REPORTED THAT ERROR WAS NOT NOTICED AND STIRRER MOTOR WAS NOISY IN EARLY PHASE AND THEN STOP FOR A MOMENT AND THEN STARTED AGAIN. IN ADDITION, IT WAS LEARNT THAT THE STIRRER MOTOR WAS REPLACED AND THE UNIT WAS PUT BACK IN SERVICE IN ITS EXPECTED FUNCTION. THE INVOLVED DEVICE WAS MANUFACTURED IN 2017 AND ACCORDING TO THE ANALYSIS OF THE COMPLAINTS DATABASE NO FURTHER EVENTS RELATED TO THIS UNIT HAVE BEEN REPORTED IN THE PAST. THE ISSUE IS MORE LIKELY ASSOCIATED TO THE MOTOR BEARING DAMAGED BY THE CORROSION, WHICH CONSEQUENTLY DOES NOT ALLOW THE MOTOR SHAFT TO ROTATE. 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 DEUTSCHLAND RECEIVED A REPORT OF NOISE AND INTERMEDIATE STOP OF A HEATER-COOLER SYSTEM 3T DURING PRIMING. NO FURTHER DETAILS ARE CURRENTLY AVAILABLE.THERE WAS NO PATIENT INVOLVEMENT.
LIVANOVA (B)(4) RECEIVED A REPORT OF NOISE AND INTERMEDIATE STOP OF A HEATER-COOLER SYSTEM 3T DURING PRIMING. NO FURTHER DETAILS ARE CURRENTLY AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080340 | HEATER-COOLER SYSTEM 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND | 16-02-80 | 04033817901099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |