CARDIOHELP
Report
- Report Number
- 8010762-2025-0000519
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- September 30, 2025
- Report Date
- December 10, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 4037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS COMPLAINT IS RELATED TO COMPLAINT ID # (B)(4) , MFG REPORT NUMBER. 8010762-2025-0000452. A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT P INTERNAL WAS DASHED OUT AND HAD FALSELY ELEVATED PRESSURES UP TO 400 MMHG. THE FAILURE WAS BRIEF ENOUGH TO NEVER HAVE THE VARYING OR DASHED OUT P INTERNAL NUMBERS. THE FAILURE OCCURRED DURING TRANSPORTATION OF A PATIENT. THE CARDIOHELP WAS NOT EXCHANGED. THE PATIENT WAS SUCCESSFULLY WEANED FROM SUPPORT TWO DAYS LATER. NO HARM TO ANY PERSON HAS BEEN REPORTED. ANY PRESSURE ISSUE OR PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP DURING TREATMENT. PATIENT INFORMATION: FEMALE, 74 YEAR OLD, 64 KG. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-10-06. THE FST OBSERVED LIQUID RESIDUE ON THE HLS CABLE. THE FAILURE COULD NOT BE REPLICATED BY THE FST. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE FST, THERE WAS SIGNS OF LIQUID RESIDUE ON THE OUTSIDE OF THE HLS CABLE. THE HLS CABLE CONNECTOR MAY HAVE BEEN WET AT THE TIME OF THE FAILURE. ANOTHER DISPOSABLE CONNECTION CABLE WITH THE SAME FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING ON 2021-03-31 DEPOSIT AND OXIDES WERE FOUND ON THE CABLE SOCKET. BY WETTING THE SOCKET PLANE WITH SALT-CONTAINING LIQUIDS (PRIMING), THE MEASUREMENT SIGNALS WERE INFLUENCED BY THE ELECTRICAL CONDUCTIVITY OF THE CONTAMINATION. A SERVICE BULLETIN (ISSUE 95 / 21-05-04) WAS PUBLISHED MAY 2021 TO MAKE THE USERS AWARE THAT THE CONTACTS OF THE PLUG CONNECTIONS MUST NOT COME INTO CONTACT WITH CLEANING AGENTS, DISINFECTANTS OR PRIMING LIQUID. MULTIPLE DISPOSABLE CONNECTION CABLES WITH THE SAME FAILURE WERE RETURNED FOR INVESTIGATION TO RE-INVESTIGATE THE ISSUE BY GETINGE LIFE-CYCLE-ENGINEERING ON 2024-08-29 (REFER TO FILE ATTACHMENT). THE VISUAL DISCOLORATION/CORROSION WAS CONFIRMED. IN ADDITION, FUNCTIONAL TESTS WERE CARRIED OUT WHICH CONFIRMED THE FOLLOWING: WETTING THE SOCKET LEVEL OF THE CONNECTOR WITH SALTY LIQUIDS (PRIMING) AFFECTS THE MEASUREMENT SIGNALS (PRESSURE MEASUREMENT) DUE TO THE INCREASED ELECTRICAL CONDUCTIVITY OF THE IMPURITIES. TO AVOID THIS CONTAMINATION, IT SHOULD BE ENSURED THAT DURING THE PRIMING PROCEDURE THE CONTACT INSIDES ARE EITHER COVERED, REMAIN ON THE HLS OR ARE PLACED ON THE HOLDER OF THE HLS CABLE OF THE SENSOR PANEL. IN ADDITION, CONTACT CLEANERS / CONTACT SPRAYS SHOULD NOT BE USED TO CLEAN THE PLUG CONTACTS. THIS WILL ALSO DAMAGE THE CONNECTIONS. 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. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-12-05 FOR THE PERIOD OF 2015-09-16 TO 2025-10-06. 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. THE DEVICE WAS MANUFACTURED ON 2015-09-16. 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 RISK REVIEW THE REPORTED FAILURE IS BELOW THE ACCEPTANCE THRESHOLD ACCORDING TO THE RISK MANAGEMENT PLAN OF THE CARDIOHELP. BASED ON THE RESULTS THE REPORTED FAILURE "PRESSURE ELEVATED ¿ HLS CABLE RESIDUE" COULD BE CONFIRMED. 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 ON (B)(6) 2025 THAT P INTERNAL WAS DASHED OUT AND HAD FALSELY ELEVATED PRESSURES UP TO 400 MMHG. THE FAILURE WAS BRIEF ENOUGH TO NEVER HAVE THE VARYING OR DASHED OUT P INTERNAL NUMBERS CAPTURED IN EPIC. NO HARM TO ANY PERSON HAS BEEN REPORTED. ANY PRESSURE ISSUE OR PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP DURING TREATMENT. COMPLAINT # (B)(4).
COMPLAINT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570716 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 4037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |