TUBING SET
Report
- Report Number
- 8010762-2025-0000301
- Event Type
- Malfunction
- Date Received
- July 17, 2025
- Date of Event
- July 8, 2025
- Report Date
- October 30, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863080383
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN THE US DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE PRESSURES OF THE HLS SET COULD NOT BE ZEROED. THE AFFECTED HLS SET WAS NOT REPLACED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WERE PRESSURE READING ISSUES DURING TREATMENT, WHICH CAN LEAD TO A PUMP STOP IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. THE CARDIOHELP DEVICE WILL BE INVESTIGATED WITHIN COMPLAINT #(B)(4) (REPORTED UNDER MFG# 8010762-2025-0000303). THE AFFECTED HLS-SET WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER. THUS, THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-08-28 WITH FOLLOWING CONCLUSION: "NO HARM TO A PATIENT, USER, OR THIRD PERSON WAS REPORTED RELATIVE TO THE EVENT. THE CORRESPONDENCE REPORTED THAT THE SENSOR CABLE FROM THE CARDIOHELP HARDWARE WAS EXCHANGED WITH A NEW CABLE, BUT THE VALUES PRESENTED ON CH WERE THE SAME AS BEFORE THE CABLE WAS REPLACED. THE COMPLAINT MENTIONED THE ¿INABILITY TO ZERO PRESSURES¿. IT IS UNKNOWN IF THE SOFTWARE ASPECT OF THE ZERO FUNCTION FOR PRESSURE WOULD NOT ALLOW ZEROING OR IF THE AFTER PRESSING ZERO ON CARDIOHELP, THE VALUES PRESENTED ON THE GUI WERE NOT CORRECT. THE FORMER FOCUSES ON THE SOFTWARE/HARDWARE ASPECT OF CARDIOHELP WHILE THE LATTER FOCUSES ON A NON-PRODUCT ASPECT (I.E., POSSIBLY USE- OR DISPOSABLE-ORIENTED). IN CORRESPONDENCE, THE USER STATED THAT ZEROING THE PRESSURES MAY HAVE BEEN PERFORMED WITH FLUID IN THE CIRCUIT, WHICH WOULD INTRODUCE OFFSET TO THE PRESSURES DISPLAYED ON THE CARDIOHELP GUI. THE PRODUCT INSTRUCTIONS FOR USE (IFU) MAKES THE FOLLOWING STATEMENT REGARDING ZEROING THE PRESSURES: INSTRUCTIONS FOR USE - HEART-LUNG SUPPORT SYSTEM CARDIOHELP SYSTEM, REV 2.0, 2024-02, 5.5.1 INTEGRATED PRESSURE SENSORS: CARRYING OUT ZERO CALIBRATION, WARNUNG CALIBRATION WITH EMPTY SYSTEM: THE SYSTEM MUST BE FREE OF LIQUIDS FOR CALIBRATING THE INTEGRATED PRESSURE SENSORS. FOR THIS REASON, CARRY OUT THE CALIBRATION BEFORE PRIMING. OTHERWISE, THE CALIBRATION MAY PRODUCE INCORRECT MEASUREMENTS, WHICH CAUSE FALSE VALUE DISPLAYS, ALARMS AND INTERVENTIONS. ZEROING THE PRESSURE SENSOR WITH FLUID IN THE CIRCUIT WILL LIKELY REPRESENT A SIGNIFICANT OFFSET DUE TO THE PRESENCE OF HYDROSTATIC PRESSURE. DEPENDING ON THE POSITION OF THE RESERVOIR AT THE TIME OF ZEROING IN THE PRESENCE OF FLUID, I.E., EITHER ABOVE OR BELOW THE LEVEL OF THE TRANSDUCERS/PRESSURE SENSORS IN THE HLS SET ADVANCED, AN OFFSET WILL PRESENT RESPECTIVE OF THE POSITION OF THE RESERVOIR AT THE TIME TRANSDUCER ZEROING. THE FACT THAT ALL THREE PRESSURES PRESENTED AS AN OFFSET IN THIS CASE (I.E., INSTEAD OF ONE) SEEMS TO BE SUGGESTIVE OF A USE ERROR RATHER THAN A PRODUCT DEFICIENCY OR MALPERFORMANCE PER SE. THE RISK (I.E., POSSIBLE HARM(S)) TO A PATIENT IS A FALSE REPRESENTATION OF THE PRESSURE DURING SUPPORT. THAT SAID, IF CLINICAL DECISIONS WERE BASED ON THE PRESSURE (AS FALSELY REPRESENTED), A CLINICIAN MAY CHOOSE TO CHANGE THE RPMS (HENCE BLOOD FLOW) TO ACHIEVE A TARGET SYSTEM PRESSURE. IN THE WORST CASE A DECREASE IN EXPECTED BLOOD FLOW (I.E., BASED ON A FALSE REPRESENTATION OF HIGH SYSTEM PRESSURE) MAY REPRESENT AS A REDUCTION IN SVO2, HYPOXIA, OR ISCHEMIA (IN THAT ORDER) AND/OR PATIENT HYPOTENSION. ON THE OTHER HAND, AN INCREASE IN EXPECTED BLOOD FLOW (I.E., BASED ON A FALSE REPRESENTATION OF LOW SYSTEM PRESSURE) MAY REPRESENT AS AN OVER-PERFUSION AND/OR PATIENT HYPERTENSION. THAT SAID, IT IS ASSUMED THAT PATIENT PRESSURE (AS TRANSDUCED IN THE PATIENT) WOULD BE THE FINAL ARBITER OF CLINICAL POSITIONING (VIZ. PRESSURE). BECAUSE THE PRODUCT WAS DISPOSED OF, A THOROUGH EXAMINATION OF THE PRODUCT CANNOT BE PERFORMED. THAT SAID, A CLEAR STRUCTURAL ROOT CAUSE (I.E., PRODUCT-RELATED) CAN BE NEITHER PROPOSED NOR DETERMINED WITHOUT AN INVESTIGATION OF BOTH PRODUCTS. A USE ERROR (I.E., A NONSTRUCTURAL ROOT CAUSE) CANNOT BE PROPOSED WITHOUT RULLING OUT THE STRUCTURAL ROOT CAUSE. LAST, A DIMINUTION IN PRODUCT PERFORMANCE (E.G., PRESSURE MEASUREMENT, BLOOD FLOW, GAS EXCHANGE, ETC.) CAN NEITHER BE ADVANCED NOR PROPOSED." DURING A COMPLAINT HISTORY REVIEW FOR HLS SETS AND CARDIOHELP DEVICE, IT WAS OBSERVED THAT PRESSURE READING ISSUES HAVE OCCURRED REPEATEDLY ON CUSTOMER SIDE. THEREFORE, TRISTAR CENTENNIAL MEDICAL CENTER REPLACED AS A PRECAUTION ALL THEIR HLS CABLES. THE SIX HLS CABLES FROM THE HOSPITAL WERE RETURNED FOR FURTHER INVESTIGATION AND WERE INVESTIGATED ON 2025-10-13 BY THE GETINGE LIFE CYCLE ENGINEERING (LCE) (UNDER COMPLAINT # (B)(4). A FOLLOW-UP MEDICAL CONSULTATION AFTER THE RECEIPT OF THE LCE INVESTIGATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-10-29 WITH THE FOLLOWING CONCLUSION: "NOTWITHSTANDING ANY INFLUENCES FROM FLUIDS OR SALTS FROM PHYSIOLOGICAL SOLUTIONS (DRIED OR WET) FOR THE HARDWARE, THE ORIGINAL ASSESSMENT (USE ERROR DURING CALIBRATION) FROM MEDICAL AFFAIRS STILL STANDS AS POSSIBLE EXPLANATIONS OF THE EVENT CITED IN THE COMPLAINT. ONE POINT THAT WAS NOT MENTIONED IN THE PREVIOUS MEDICAL AFFAIRS CONSULTATION IS THE REQUIREMENT TO SET RPMS TO ZERO TO ALLOW CALIBRATION. THAT SAID, IT WAS ASSUMED (PREVIOUSLY) THAT 0 RPMS WERE SET WHEN CALIBRATION WAS ATTEMPTED. SPEAKING TO THE PREVIOUS CONSULT, THE USER STATED THAT ZEROING THE PRESSURES MAY HAVE BEEN PERFORMED WITH FLUID IN THE CIRCUIT, WHICH WOULD INTRODUCE OFFSET TO THE PRESSURES DISPLAYED ON THE CARDIOHELP GUI. AS STATED PREVIOUSLY, ZEROING THE PRESSURE SENSOR WITH FLUID IN THE CIRCUIT WILL LIKELY REPRESENT A SIGNIFICANT OFFSET DUE TO THE PRESENCE OF HYDROSTATIC (COLUMN) PRESSURE. DEPENDING ON THE POSITION OF THE RESERVOIR AT THE TIME OF ZEROING IN THE PRESENCE OF FLUID, I.E., EITHER ABOVE OR BELOW THE LEVEL OF THE TRANSDUCERS/PRESSURE SENSORS IN THE HLS SET ADVANCED, AN OFFSET WILL PRESENT RESPECTIVE OF THE POSITION OF THE RESERVOIR AT THE TIME TRANSDUCER ZEROING. FROM THE DATA PRESENTED IN THE INVESTIGATION REPORT, THE SENSOR CABLES FUNCTIONED AS EXPECTED WHEN DRY, BUT A MEASURABLE OFFSET WAS DEMONSTRATED WHEN THE SENSOR CABLE WAS HUMIDIFIED (WET)." ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0 PREPARATION AND INSTALLATION ¿CARRY OUT THE CALIBRATION FOR EACH PRESSURE PARAMETER OF THE INTEGRATED SENSORS. TO DO THIS, THE SYSTEM MUST BE FREE OF LIQUIDS. FOR THIS REASON, CARRY OUT THE CALIBRATION BEFORE PRIMING THE SET.¿ THE GETINGE SALES AND SERVICE UNIT CONFIRMED THAT THE OPERATOR IS ZEROING THE PRESSURES IN DRY STATE, HOWEVER THE OPERATORS DO NOT DENY THAT IT MAY HAVE ATTEMPTED TO PERFORM THE ZEROING AFTER PRIMING THE SYSTEM. THEREFORE, THE CUSTOMER WILL BE INFORMED TO PERFORM THE CALIBRATION OF THE PRESSURE PARAMETERS BEFORE PRIMING ACCORDING TO THE IFU. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-09-17. ACCORDING TO THE FINAL TEST RESULTS, THE MODULE WITH LOT# 3000470556 PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AND NO ABNORMALITIES IN REGARD TO THE REPORTED FAILURE WERE FOUND. 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. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED FAILURE. 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.
THE AFFECTED HLS-SET WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER. A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025. FURTHERMORE, THE HLS CABLE INVOLVED IN THIS EVENT WAS SENT BACK FOR FURTHER INVESTIGATION. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
COMPLAINT ID (B)(4).
COMPLAINT ID (B)(4).
THE EVENT OCCURRED IN THE US DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE PRESSURE OF THE HLS SET COULD NOT BE ZEROED. THE AFFECTED HLS SET WAS NOT REPLACED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 1572049 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET ADVANCED | 3000473887 | 04058863080383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male |