CARDIOHELP
Report
- Report Number
- 8010762-2025-0000328
- Event Type
- Malfunction
- Date Received
- July 31, 2025
- Date of Event
- July 23, 2025
- Report Date
- October 31, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04058863074863
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THERE WERE IRREGULAR PRESSURE READINGS AND LOUD NOISE COMING FROM THE PUMP. THE FAILURE OCCURRED DURING TREATMENT. THE PATIENT WAS WEANED OFF ON (B)(6) 2025. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE DEVICE CAUSED THE COMPLAINT AND WAS NOT ABLE TO WORK AS PER FACTORY¿S SPECIFICATIONS. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. THE GETINGE SERVICE AND SALES UNIT CONFIRMED WITHIN THE RELATED HLS SET COMPLAINT (COMPLAINT: (B)(4), MFG REPORT NUMBER: 8010762-2025-0000327) THAT THE PATIENT DATA IS UNKNOWN. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-10-24. THE FST CONFIRMED THAT THERE WAS NO VISIBLE DAMAGE BUT THE ENTIRE UNIT WAS VERY DUSTY/DIRTY INCLUDING EXCESSIVE DUST ON THE FANS WITHIN THE COOLING ELEMENT. THEREFORE, THE FANS WERE CAUSING THE LOUD NOISE AND WERE REPLACED. THE PRESSURE READING ISSUE COULD NOT BE REPLICATED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ANOTHER FAN WITH THE SAME ISSUE WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2017-09-11. A LOT OF DUST AT THE BOX AND THE ROTORS OF BOTH FANS WAS DETERMINED IN THE INVESTIGATION. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS A TEMPORARY BLOCKING OF THE FANS BY AN ACCUMULATION OF DUST. THE ROOT CAUSE FOR THE PRESSURE READING ISSUE WAS RELATED TO THE HLS SET, WHICH WILL BE INVESTIGATED IN COMPLAINT#: (B)(4). ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.4, CHAPTER "PREPARATION AND INSTALLATION" AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER "PRIMING THE SYSTEM") THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. FURTHERMORE, THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE 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. ADDITIONALLY, ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP, CHAPTER "CONNECTION THE SENSORS", IT IS STATED TO ENSURE THAT THE CONNECTED SENSORS ARE NOT DEFECTIVE AND TO NOT USE IF THERE IS A VISIBLE DAMAGE. IN THE INSTRUCTIONS FOR USE (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 THE IFU CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. IN THE CARDIOHELP INSTRUCTIONS FOR USE (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. IN THE INSTRUCTION FOR USE (IFU) IS STATED THAT IT IS NECESSARY TO DECREASE THE FLOW TO ZERO BEFORE DISCONNECTING AND CONNECTING THE DISPOSABLE TO THE DEVICE. THE SYSTEM HAS REDUNDANT FANS TO ENSURE A PROPER COOLING EVEN IF ONE FAN MALFUNCTIONS. IN CASE OF A DEFECTIVE FAN A VISUAL AND ACOUSTIC ALARM IS GENERATED. IN ADDITION AN ALARM IS GENERATED IF THE INTERNAL TEMPERATURE IS TOO HIGH. ACCORDING TO THE SERVICE MANUAL (CHAPTER "SERVICE ACTIVITIES") THE FANS HAVE TO BE EXCHANGED EVERY 24 MONTHS DURING THE MAINTENANCE. FURTHERMORE IN THE INSTRUCTION FOR USE (IFU), (CHAPTER "GENERAL RISKS IN THE USE OF HEART-LUNG SUPPORT SYSTEMS") IT IS STATED THAT THE VENTILATION OPENINGS HAVE TO BE CHECKED BEFORE EVERY USE THAT THEY ARE NOT COVERED. A CARDIOHELP WITH A DEFECTIVE FAN SHOULD BE REPLACED AS QUICKLY AS POSSIBLE. FOR BOTH FAILURES: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-10-27 OR THE PERIOD OF 2020-10-13 TO 2025-07-28. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURES. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE DEVICE WAS MANUFACTURED ON 2020-10-13. 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 "NOISE" COULD BE CONFIRMED AND THE REPORTED FAILURE "PRESSURE READING ISSUE" COULD NOT BE CONFIRMED FOR THE CARDIOHELP DEVICE AND IS RELATED TO THE HLS SET. 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.
A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
COMPLAINT ID#: (B)(4).
THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT THERE WERE IRREGULAR PRESSURE READINGS AND LOUD NOISE COMING FROM THE PUMP. PATIENT WAS WEANED OFF (B)(6) 2025. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE HLS SET WILL BE INVESTIGATED IN COMPLAINT (B)(4). AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48634 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 04058863074863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |