CARDIOHELP
Report
- Report Number
- 8010762-2025-0000518
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- October 28, 2025
- Report Date
- December 2, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE FAILURE COULD NOT BE REPLICATED AND NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED.NOTE: THIS EVENT OCCURRED ON THE CANADA MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.
IT WAS REPORTED THAT THE CARDIOHELP DISPLAYED THE ERROR MESSAGE ¿ARTERIAL BUBBLE SENSOR DEFECTIVE¿ DURING TREATMENT. THE FAILURE OCCURRED AFTER THE PATIENT WAS TRANSFERRED TO THE CVICU. THE CARDIOHELP CONSOLE WAS NEVER SWAPPED, ONLY THE FBS HAD BEEN SWAPPED. BY THE TIME THE FBS WAS SWAPPED THE ERROR RESOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FOLLOWING PATIENT DATES RECEIVED: FEMALE, AGED 65, WEIGHT 53KG.AS THE FAILURE OCCURRED DURING TREATMENT AND THE A BUBBLE ALARM IS A HIGH PRIORITY ALARM, A REPORT IS NEEDED.A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE FAILURE COULD NOT BE REPLICATED AND NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. AS THE FAILURE COULD NOT BE REPLICATED, THE ROOT CAUSE REMAINS UNKNOWN.HOWEVER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE:- INFLUENCE DUE TO OTHER ULTRASONIC DEVICES (E.G. FLOW SENSOR)- BUBBLE SENSOR DISTURBED- BUBBLE SENSOR NOT PLUGGED BUT RECOGNIZED CONNECTION OF NON-COMPATIBLE SENSOR- ENVIRONMENTAL INFLUENCES (ATMOSPHERIC PRESSURE, TEMPERATURE, HUMIDITY, EMI, OVERVOLTAGE)- BUBBLE SENSOR CANNOT BE PLUGGED .THE DEVICE WAS MANUFACTURED ON 2020-05-19.THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-11-19 FOR THE PERIOD OF 2020-05-19 TO 2025-10-28. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS.ACCORDING TO THE INSTRUCTION FOR USE (IFU) CHAPTER "CONNECTING THE COMBINED FLOW/BUBBLE SENSOR" THE BUBBLE MONITORING FUNCTION TEST AND FLOW OFF-SET CALIBRATION HAS TO BE PERFORMED BEFORE EVERY USE. THUS A DEFECTIVE FLOW/BUBBLE SENSOR SHOULD BE DETECTED PRIOR TO USE, DURING PRIMING. IN ADDITION AS THE CARDIOHELP INCLUDES PRESSURE SENSORS AND A VENOUS PROBE IT IS ABLE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. IN THE IFU CHAPTER "USING THE EMERGENCY DRIVE WITH THE DISPOSABLE HLS RETAINER" IS STATED THAT THE EMERGENCY DRIVE CAN BE USED TO MANUALLY CONTROL THE BLOOD FLOW IN CASE OF A FAILED CARDIOHELP.ACCORDING TO THE IFU OF THE CARDIOHELP CHAPTER "CLEANING AND DISINFECTION", THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURTHERMORE, IN CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN.THE DEVICE WAS MANUFACTURED ON 2020-05-19.THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-11-19 FOR THE PERIOD OF 2020-05-19 TO 2025-10-28. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS.BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE ¿ARTERIAL BUBBLE SENSOR DEFECTIVE¿ COULD NOT BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT.THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY'S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
IT WAS REPORTED THAT THE CARDIOHELP DISPLAYED THE ERROR MESSAGE ¿ARTERIAL BUBBLE SENSOR DEFECTIVE¿ DURING TREATMENT. THE FAILURE OCCURRED AFTER THE PATIENT WAS TRANSFERRED TO THE CVICU. THE CARDIOHELP CONSOLE WAS NEVER SWAPPED, ONLY THE FBS HAD BEEN SWAPPED. BY THE TIME THE FBS WAS SWAPPED THE ERROR RESOLVED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2830249 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 04037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |