TUBING SET
Report
- Report Number
- 8010762-2026-0000044
- Event Type
- Malfunction
- Date Received
- February 4, 2026
- Report Date
- March 19, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WAS RECEIVED ON 2026-02-11 FROM THE CUSTOMER TO CLARIFY THE EVENTS. THE FIRST HLS SET STARTED TO MAKE NOISE ON (B)(6) 2026, WHEN THE PATIENT WAS ON SUPPORT SINCE 8 DAYS. THE CUSTOMER STATED THAT THE NOISE WAS MOST PROBABLE TO CLOTS AS THERE WERE ANTICOAGULATION DIFFICULTIES. THIS HLS SET WAS REPLACED TWO DAYS LATER, ON (B)(6) 2026 FOR A NEW HLS SET. ON (B)(6) 2026, THE SECOND USED HLS SET ON THE PATIENT, WHICH WAS PRIMED ON THE SAME DATE AS THE FIRST HLS SET, STARTED TO MAKE A NOISE WITH FLOW AND PRESSURE READING ISSUES. THEREFORE, THE CUSTOMER MADE THE DECISION TO REPLACE THE SECOND HLS SET, AS WELL AS THE CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT WHILE ON THE PATIENT THE CARDIOHELP PUMP STARTED TO MAKE A ¿ROCK TUMBLING¿ NOISE. FURTHER THE NOISE WAS PAIRED WITH SIGNIFICANT VARIABILITY IN FLOW AND PRESSURE READING. THE CUSTOMER ASSUMED THE THIS WAS CAUSED BY CLOTS WITHIN THE OXYGENATOR. THE HLS SET AND THE CARDIOHELP DEVICE WERE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED CARDIOHELP WILL BE INVESTIGATED IN COMPLAINT# (B)(4). (MFG REPORT NUMBER 8010762-2026-0000043). THE CARDIOHELP DEVICE WAS LATER PRIMED AGAIN. THE CARDIOHELP CONTINUED TO MAKE A NOISE AND SHOWED SIGNIFICANT VARIABILITY IN PRESSURE VALUES. THE CUSTOMER ASSUMED THAT THE CARDIOHELP DEVICE HAS MECHANICAL ISSUES. THE SECOND EVENT DURING PRIMING WITH ANOTHER DISPOSABLE WILL BE INVESTIGATED IN CARDIOHELP COMPLAINT# (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 2026-01-26 THAT THE HLS CABLE WAS FOUND DEFECTIVE BY THE GETINGE TECHNICIAN. THE PRESSURE VALUES CHANGED WHEN THE CABLE WAS MOVED AROUND. A NEW HLS CABLE WAS SENT TO THE CUSTOMER. THE GETINGE TECHNICIAN CONFIRMED THAT THE HLS CABLE DID NOT SHOW ANY SIGNS OF PHYSICAL DAMAGE. NEW INFORMATION WAS RECEIVED ON 2026-01-30 THAT THE NOISE DURING TREATMENT OCCURRED ON (B)(6) 2026. FOLLOWING PATIENT DATA WAS SHARED: MALE, 16 YEARS OLD WITH 63KG. THE AFFECTED LOT OF THE HLS SET IS NOT AVAILABLE AS IT WAS NOT KEPT, NOTED OR SCANNED BY THE CUSTOMER. THE HLS SET WAS DISCARDED BY THE CUSTOMER. THE HLS SET WAS REPLACED AND THERE WERE CLOTS IN THE CIRCUIT, BUT NON VISIBLE IN THE OXYGENATOR. THE CUSTOMER CONFIRMED THAT THE HLS SET WAS SEATED/INSERTED CORRECTLY INTO THE CARDIOHELP DEVICE, BUT NO RE-SEATING/REINSERTION WAS MADE. THERE WAS NO VISIBLE DAMAGE ON THE HLS SET. THE HLS SET WAS PRIMED ON (B)(6) 2026. THE ANTICOAGULATION BIVALIRUDIN WAS USED AT THE BEGINNING OF TREATMENT, THEN NO ANTICOAGULATION WAS USED FOR A FEW HOURS AND IT WAS THAN LATER CHANGED TO HEPARIN. THE ANTICOAGULANT WAS ADMINISTERED AT THE START OF THE HLS SET USE. ADDITIONAL INFORMATION WAS RECEIVED ON 2026-02-11 FROM THE CUSTOMER TO CLARIFY THE EVENTS. THE FIRST HLS SET STARTED TO MAKE NOISE ON (B)(6) 2026, WHEN THE PATIENT WAS ON SUPPORT SINCE 8 DAYS. THE CUSTOMER STATED THAT THE NOISE WAS MOST PROBABLE TO CLOTS AS THERE WERE ANTICOAGULATION DIFFICULTIES. THIS HLS SET WAS REPLACED TWO DAYS LATER, ON (B)(6) 2026 FOR A NEW HLS SET. ON (B)(6) 2026, THE SECOND USED HLS SET ON THE PATIENT, WHICH WAS PRIMED ON THE SAME DATE AS THE FIRST HLS SET, STARTED TO MAKE A NOISE WITH FLOW AND PRESSURE READING ISSUES. THEREFORE THE CUSTOMER MADE THE DECISION TO REPLACE THE SECOND HLS SET, AS WELL AS THE CARDIOHELP. AS THE HLS SET WAS REPLACED DURING TREATMENT TWICE, A REPORT IS REQUIRED. THE AFFECTED HLS SETS WERE DISCARDED BY THE CUSTOMER, THEREFORE THE EXACT ROOT CAUSE REMAINS UNKNOWN. A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2026 WITH FOLLOWING CONCLUSION: "PROBABLE ROOT CAUSES: 1. PRESSURE VARIABILITY. CONFIRMED ROOT CAUSE: DEFECTIVE HLS OXYGENATOR CABLE CAUSING SIGNIFICANT VARIABILITY IN PRESSURE READINGS. DURING TECHNICAL EVALUATION, THE SERVICE TECHNICIAN IDENTIFIED THAT PRESSURE VALUES CHANGED WHEN THE HLS OXYGENATOR CABLE WAS MANIPULATED. AFTER CABLE REPLACEMENT, PRESSURE READINGS STABILIZED, AND NO FURTHER ABNORMALITIES WERE OBSERVED. THIS ESTABLISHES A CONFIRMED ROOT CAUSE FOR THE REPORTED PRESSURE VARIABILITY DURING BOTH EVENTS. 2) ¿ROCK TUMBLING¿ NOISE DURING SUPPORT. FLOW DISTURBANCES WITHIN THE HLS SETS, POSSIBLY INFLUENCED BY REPORTED CLOTTING IN THE CIRCUIT AND ANTICOAGULATION CHALLENGES. (DISPOSABLE WAS DISCARDED; CANNOT BE VERIFIED TECHNICALLY.) POTENTIAL DECOUPLING OF THE HLS SET CENTRIFUGAL PUMP FROM THE PUMP DRIVE OF THE CARDIOHELP CONSOLE. A TEMPORARY MECHANICAL DECOUPLING BETWEEN THE MAGNETICALLY DRIVEN PUMP HEAD AND THE CONSOLE DRIVE UNIT COULD THEORETICALLY GENERATE ABNORMAL MECHANICAL NOISE AND FLOW INSTABILITY. HOWEVER, NO DECOUPLING ALARM WAS REPORTED, AND NO MECHANICAL MALFUNCTION COULD BE REPRODUCED DURING POST-SERVICE FUNCTIONAL TESTING. THROMBUS FORMATION WITHIN THE CENTRIFUGAL PUMP HEAD. A THROMBUS LOCATED WITHIN THE PUMP HEAD COULD POTENTIALLY PRODUCE ABNORMAL NOISE AND FLOW DISTURBANCES. SUCH THROMBUS FORMATION WOULD TYPICALLY BE VISUALLY IDENTIFIABLE UPON INSPECTION OF THE DISPOSABLE PUMP HEAD DURING AND/OR AFTER SUPPORT. HOWEVER, NO SUCH THROMBUS WAS REPORTED BY THE COMPLAINT NARRATIVE. AS THE DISPOSABLE WAS DISCARDED, THIS POTENTIAL CAUSE CANNOT BE TECHNICALLY EXCLUDED BUT IS NOT SUPPORTED BY THE AVAILABLE INFORMATION. INFLUENCE OF PRESSURE-BASED INTERVENTION THRESHOLDS SECONDARY TO ERRATIC PRESSURE MEASUREMENTS CAUSED BY THE DEFECTIVE HLS OXYGENATOR CABLE. ERRATIC PRESSURE READINGS MAY HAVE TRIGGERED SYSTEM RESPONSES OR PUMP SPEED ADJUSTMENTS WITHIN SET SAFETY THRESHOLDS, POTENTIALLY CONTRIBUTING TO SIGNIFICANT FLOW FLUCTUATIONS AND ASSOCIATED ACOUSTIC CHANGES. GIVEN THAT THE DEFECTIVE PRESSURE CABLE WAS CONFIRMED TO PRODUCE FLUCTUATIONS IN PRESSURE VALUES, IT IS PLAUSIBLE THAT INACCURATE PRESSURE FEEDBACK MAY HAVE INFLUENCED PUMP REGULATION BEHAVIOR. NO ADDITIONAL DETAILED SYSTEM LOG DATA OR FURTHER TECHNICAL INFORMATION WAS PROVIDED BY THE CUSTOMER TO ALLOW CONFIRMATION OF THIS MECHANISM. POTENTIAL RISK TO PATIENT: - RISK OF COMPROMISED FLOW STABILITY DURING ECMO SUPPORT. FLOW VARIABILITY DURING SUPPORT MAY THEORETICALLY AFFECT HEMODYNAMIC STABILITY OR GAS EXCHANGE EFFICIENCY. HOWEVER, NO ADVERSE CLINICAL CONSEQUENCE WAS REPORTED. - RISK OF INACCURATE PRESSURE MONITORING . A DEFECTIVE PRESSURE CABLE MAY RESULT IN UNSTABLE DISPLAYED PRESSURE VALUES, POTENTIALLY COMPLICATING CLINICAL INTERPRETATION. IN ADDITION, ERRATIC PRESSURE READINGS MAY INTERACT WITH USER-DEFINED PRESSURE INTERVENTION THRESHOLDS. IF SUCH THRESHOLDS WERE CONFIGURED AND ACTIVATED BY THE CUSTOMER, FALSELY ELEVATED OR FLUCTUATING PRESSURE VALUES COULD HAVE BEEN INTERPRETED BY THE SYSTEM AS THRESHOLD EXCEEDANCES, POTENTIALLY TRIGGERING AUTOMATIC PUMP FLOW ADJUSTMENTS OR TRANSIENT FLOW REDUCTIONS. THIS MECHANISM MAY HAVE CONTRIBUTED TO THE OBSERVED FLOW VARIABILITY. - RISK ASSOCIATED WITH CIRCUIT CLOTTING. REPORTED CLOT FORMATION WITHIN THE CIRCUIT MAY INCREASE RESISTANCE AND PREDISPOSE TO CIRCUIT EXCHANGE. ANTICOAGULATION CHALLENGES DURING TREATMENT LIKELY CONTRIBUTED TO THROMBOTIC RISK. NEVERTHELESS, THE SITUATION WAS CLINICALLY MANAGED, AND NO EMBOLIC EVENT OR PATIENT HARM WAS REPORTED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE ACOUSTIC PHENOMENON AND FLOW FLUCTUATIONS DURING TREATMENT CANNOT BE CONCLUSIVELY DETERMINED, AS THE INVOLVED HLS SETS WERE DISCARDED AND THEREFORE NOT AVAILABLE FOR RETURN AND FURTHER INVESTIGATION. WITHOUT PHYSICAL INSPECTION OR FUNCTIONAL TESTING OF THE DISPOSABLES, CONFIRMATION OR EXCLUSION OF CLOT FORMATION WITHIN THE OXYGENATOR OR PUMP HEAD IS NOT POSSIBLE. ALTHOUGH THROMBUS WITHIN THE CENTRIFUGAL PUMP MAY HAVE BEEN VISUALLY DETECTABLE, ITS PRESENCE CANNOT BE FULLY RULED OUT BASED ON THE AVAILABLE INFORMATION. BASED ON THE COMPLAINT DESCRIPTION AND TECHNICAL FINDINGS, THE MOST PROBABLE CONTRIBUTING FACTORS INCLUDE FLOW DISTURBANCES WITHIN THE DISPOSABLE CIRCUIT POTENTIALLY ASSOCIATED WITH REPORTED CLOT FORMATION AND ANTICOAGULATION INSTABILITY, AND ERRATIC PRESSURE SIGNALS GENERATED BY THE CONFIRMED DEFECTIVE HLS OXYGENATOR CABLE. THE UNSTABLE PRESSURE READINGS MAY HAVE INTERACTED WITH USER-DEFINED PRESSURE INTERVENTION THRESHOLDS, POTENTIALLY TRIGGERING AUTOMATIC PUMP FLOW ADJUSTMENTS OR TRANSIENT FLOW VARIATIONS THAT COULD EXPLAIN THE REPORTED SIGNIFICANT FLOW FLUCTUATIONS AND ASSOCIATED NOISE. IMPORTANTLY, AFTER REPLACEMENT OF THE DEFECTIVE CABLE, THE CARDIOHELP DEMONSTRATED NORMAL AND STABLE OPERATION UNDER CONTROLLED TEST CONDITIONS. NO FURTHER PRESSURE ABNORMALITIES, FLOW INSTABILITY, OR ACOUSTIC IRREGULARITIES WERE OBSERVED, AND NO INTRINSIC DEVICE MALFUNCTION COULD BE REPRODUCED. NO ADVERSE PATIENT OUTCOME, OR PATIENT HARM WAS REPORTED. THE CLINICAL TEAM APPROPRIATELY MANAGED THE SITUATION, INCLUDING PRECAUTIONARY CIRCUIT EXCHANGE. " ACCORDING TO THE INSTRUCTIONS OF USE OF THE HLS SET (CHAPTER SAFETY INSTRUCTIONS FOR CENTRIFUGAL PUMP) IT IS STATED THAT TO LISTEN FOR SCRATCHING NOISES WHEN PRIMING THE SYSTEM AND TO REPLACE THE HLS SET ADVANCED IF THERE ARE SCRATCHING NOISES. REFERRING TO THE INSTRUCTION OF USE OF THE HLS SET IN CHAPTER "SAFETY INSTRUCTIONS FOR THE EXTRACORPOREAL CIRCULATION" IT IS STATED THAT NO ANTICOAGULATION OR INSUFFICIENT ANTICOAGULATION CAUSES OCCLUSION OF THE EXTRACORPOREAL CIRCULATION AND THE PATIENT CIRCUIT. THIS CAN LEAD TO INADEQUATE PATIENT SUPPORT, HEMOLYSIS OR THROMBUS FORMATION IN THE PATIENT. IT IS RECOMMENDED TO USE ANTICOAGULANTS; E.G. HEPARIN OR ARGATROBAN AND TO CHECK THE EFFECT OF ANTICOAGULANTS AT REGULAR INTERVALS BY MEASURING THE ACT (ACTIVATED CLOTTING TIME). ENSURE THAT THE ACT VALUE DOES NOT FALL BELOW THE VALUE WHICH IS APPROPRIATE FOR THE APPLICATION. FURTHER THE COAGULATION STATUS OF THE PATIENT'S BLOOD SHOULD BE CHECKED REGULARLY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS, PRODUCTION DOCUMENTS, DEVICE HISTORIY REVIEW AND DESIGN CHANGES COULD NOT BE PERFORMED, AS THE AFFECTED SET LOT WAS NOT PROVIDED BY THE CUSTOMER. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURES AND PRODUCTS 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 REGARDS TO THE REPORTED FAILURES. BASED ON THE RESULTS THE REPORTED FAILURE "NOISE, FLOW AND CLOTTING ISSUE" COULD NOT BE CONFIRMED. THE FAILURE "PRESSURE READING ISSUE" COULD BE CONFIRMED, BUT WAS RELATED TO THE CARDIOHELP. 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THE DISPOSABLE WAS DISCARDED BY THE CUSTOMER. THEREFORE IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THE DISPOSABLE WAS DISCARDED BY THE CUSTOMER. THEREFORE IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
COMPLAINT ID (B)(4).
COMPLAINT ID (B)(4).
THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT WHILE ON THE PATIENT THE CARDIOHELP PUMP STARTED TO MAKE A ¿ROCK TUMBLING¿ NOISE. FURTHER THE NOISE WAS PAIRED WITH SIGNIFICANT VARIABILITY IN FLOW AND PRESSURE READING. THE CUSTOMER ASSUMED THE THIS WAS CAUSED BY CLOTS WITHIN THE OXYGENATOR. THE HLS SET AND THE CARDIOHELP DEVICE WERE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED CARDIOHELP WILL BE INVESTIGATED IN COMPLAINT# (B)(4). THE CARDIOHELP DEVICE WAS LATER PRIMED AGAIN. THE CARDIOHELP CONTINUED TO MAKE A NOISE AND SHOWED SIGNIFICANT VARIABILITY IN PRESSURE VALUES. THE CUSTOMER ASSUMED THAT THE CARDIOHELP DEVICE HAS MECHANICAL ISSUES. THE SECOND EVENT DURING PRIMING WITH ANOTHER DISPOSABLE WILL BE INVESTIGATED IN CARDIOHELP COMPLAINT# (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 2026-01-26 THAT THE HLS CABLE WAS FOUND DEFECTIVE BY THE GETINGE TECHNICIAN. THE PRESSURE VALUES CHANGED WHEN THE CABLE WAS MOVED AROUND. A NEW HLS CABLE WAS SENT TO THE CUSTOMER. THE GETINGE TECHNICIAN CONFIRMED THAT THE HLS CABLE DID NOT SHOW ANY SIGNS OF PHYSICAL DAMAGE. NEW INFORMATION WAS RECEIVED ON (B)(6) 2026 THAT THE NOISE DURING TREATMENT OCCURRED ON (B)(6) 2026. FOLLOWING PATIENT DATA WAS SHARED: MALE, 16 YEARS OLD WITH 63KG. THE AFFECTED LOT OF THE HLS SET IS NOT AVAILABLE AS IT WAS NOT KEPT, NOTED OR SCANNED BY THE CUSTOMER. THE HLS SET WAS DISCARDED BY THE CUSTOMER. THE HLS SET WAS REPLACED AND THERE WERE CLOTS IN THE CIRCUIT, BUT NON-VISIBLE IN THE OXYGENATOR. THE CUSTOMER CONFIRMED THAT THE HLS SET WAS SEATED/INSERTED CORRECTLY INTO THE CARDIOHELP DEVICE, BUT NO RE-SEATING/REINSERTION WAS MADE. THERE WAS NO VISIBLE DAMAGE ON THE HLS SET. THE HLS SET WAS PRIMED ON (B)(6) 2026. THE ANTICOAGULATION BIVALIRUDIN WAS USED AT THE BEGINNING OF TREATMENT, THEN NO ANTICOAGULATION WAS USED FOR A FEW HOURS AND IT WAS THAN LATER CHANGED TO HEPARIN. THE ANTICOAGULANT WAS ADMINISTERED AT THE START OF THE HLS SET USE. AS THE HLS SET WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107119 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Male |