BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUBING SET

    MDR report key: 23078009 · Received September 17, 2025

    Report

    Report Number
    3013876692-2025-00083
    Event Type
    Death
    Date Received
    September 17, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863078298
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ES
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE EL SALVADOR MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069076.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN EL SALVADOR DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET HAD A PLASMA LEAK IN THE DE-AIRING MEMBRANE CONNECTOR COMPARTMENT ON THE SECOND DAY OF ECMO THERAPY. THE PATIENT¿S INDICATION FOR ECMO WAS A DENGUE SHOCK. THERE WERE NO ABNORMALITIES IN PRESSURE OR FLOW PARAMETERS, NOR IN OXYGENATION; ALL LEVELS WERE WITHIN THE REQUIRED RANGE. THE HLS SET WAS NOT REPLACED. THE ECMO THERAPY WAS SUCCESSFULLY COMPLETED, AND THE HLS SET WAS DISCONNECTED. ON (B)(6) 2025 THE INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY A FEW DAYS AFTER THE ECMO WAS COMPLETED. AS THE HLS SET HAD A LEAKAGE DURING TREATMENT AND THE INVOLVED PATIENT PASSED AWAY, A REPORT IS REQUIRED. THE AFFECTED PRODUCT WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER. THUS, THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, A MEDICAL REVIEW WAS PERFORMED ON (B)(6) 2025 WITH FOLLOWING CONCLUSION: "BASED ON THE AVAILABLE INFORMATION, THE POTENTIAL PLASMA LEAKAGE OCCURRED ON THE SECOND DAY OF EXTRACORPOREAL SUPPORT FOR A PEDIATRIC PATIENT DIAGNOSED WITH DENGUE SHOCK. DENGUE SHOCK SYNDROME (DSS) REPRESENTS ONE OF THE MOST SEVERE MANIFESTATIONS OF DENGUE VIRUS INFECTION. DENGUE SHOCK SYNDROME (DSS) IS A DANGEROUS COMPLICATION OF THE DENGUE INFECTION THAT IS ASSOCIATED WITH ADMISSION TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) AND MORTALITY RATES OF 1%¿26%. WHO REPORTED IN 2017 THAT SEVERE DENGUE CASES, IF NOT HANDLED PROPERLY, HAD A MORTALITY RATE OF AROUND 20 %. IN ADDITION TO SHOCK, UNCONTROLLED BLEEDING, AND MULTIPLE ORGAN FAILURE, ACUTE RESPIRATORY FAILURE (ARF) IS AN IMPORTANT COMPLICATION THAT CAN LEAD TO DEATH. THE REPORTED PLASMA LEAKAGE WAS OBSERVED AT THE DE-AIRING MEMBRANE OF THE HLS-OXYGENATOR. NO ABNORMALITIES WERE REPORTED IN BLOOD FLOW RATES, TRANSMEMBRANE PRESSURES, OXYGENATION PARAMETERS, OR OVERALL OXYGENATOR PERFORMANCE. BASED ON THE AVAILABLE DATA, SEVERAL POTENTIAL ROOT CAUSES FOR THE REPORTED ISSUE AT THE DEAIRING MEMBRANE COMPARTMENT ARE LIKELY: - USE DEVIATION: THE YELLOW DE-AIRING PORT, WHICH IS REQUIRED TO REMAIN CLOSED AFTER PRIMING PER THE INSTRUCTIONS FOR USE (IFU), WAS REPEATEDLY OPENED AND CLOSED DURING THERAPY. ADDITIONALLY, THE PORT WAS (APPARENTLY) USED FOR THE ADMINISTRATION OF PLASMA. THIS DEVIATION MAY HAVE COMPROMISED THE MEMBRANE INTEGRITY, LEADING TO PLASMA LEAKAGE. - MANUFACTURING OR MATERIAL DEFECT: WITHOUT ACCESS TO THE AFFECTED PRODUCT, IT IS NOT POSSIBLE TO RULE OUT A POTENTIAL DEFECT IN MATERIALS OR MANUFACTURING PROCESSES. - PRESSURE-RELATED FACTORS: TRANSIENT HIGH PRESSURE IN THE BLOOD OR GAS COMPARTMENTS DURING PRIMING OR PERFUSION MAY HAVE CREATED AN ENVIRONMENT IN WHICH SEEPAGE OF PROTEIN THROUGH THE DEAIRING PORT WAS EXACERBATED. AS NO SERVICE RECORDS, LOG FILES, OR ENGINEERING INVESTIGATION REPORTS WERE AVAILABLE FOR FURTHER TECHNICAL ANALYSIS, AS THE AFFECTED PRODUCT WAS DISPOSED NONE OF THE ABOVE-MENTIONED POSSIBLE ROOT CAUSES CAN BE RULED OUT, NOR CAN IT BE CONFIRMED. ALTHOUGH NO PERFORMANCE ISSUES WERE REPORTED, AN OPEN DEAIRING PORT DURING USE MAY ALLOW THE INTRODUCTION OF AMBIENT AIR INTO THE CIRCUIT WHICH MAY RESULT IN AIR EMBOLISM. AIR ENTRAINMENT (THROUGH AN OPEN DEAIRING PORT) WOULD REQUIRE A PUMP STOP AND THE ELEVATION OF THE HLS MODULE TO A LEVEL ABOVE THE HEART/PATIENT. ACCORDING TO THE HLS SET INSTRUCTION FOR USE CHAPTER 5.3.1, THE YELLOW PROTECTIVE CAP SHOULD BE PLACED BACK ON THE DEAIRING PORT AFTER PRIMING. AS THE PRODUCT COULD NOT BE EXAMINED BY GETINGE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED PLASMA LEAK IS NOT DISCERNABLE; THEREFORE, A PRODUCT DEFICIENCY CAN NEITHER BE CONFIRMED NOR RULED OUT." THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-10-13. ACCORDING TO THE FINAL TEST RESULTS, THE PRODUCT PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AN NO ABNORMALITIES IN REGARDS 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 REGARDS TO THE REPORTED FAILURE. ACCORDING TO THE INSTRUCTION FOR USE (HLS SET, CHAPTER, "SAFETY INSTRUCTIONS FOR THE OXYGENATOR") ENSURE THAT THE DE-AIRING MEMBRANE OF THE OXYGENATOR IS CLOSED WITH THE YELLOW PROTECTIVE CAP DURING OPERATION. BASED ON THE RESULTS AND THE PROVIDED PHOTOGRAPHICAL EVIDENCE BY THE CUSTOMER, THE REPORTED FAILURE "PLASMA LEAK IN THE DE-AIRING MEMBRANE CONNECTOR" COULD BE CONFIRMED. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE HLS SET (ARTICLE #701069076) AS A SINGLE EVENT (TIMEFRAME FROM 2024-09-05 TILL 2025-09-05). 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. NOTE: THIS EVENT OCCURRED ON THE EL SALVADOR MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069076.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN (B)(6) DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET HAD A PLASMA LEAK IN THE DE-AIRING MEMBRANE CONNECTOR COMPARTMENT ON THE SECOND DAY OF ECMO THERAPY. THE PATIENT¿S INDICATION FOR ECMO WAS A DENGUE SHOCK. THERE WERE NO ABNORMALITIES IN PRESSURE OR FLOW PARAMETERS, NOR IN OXYGENATION; ALL LEVELS WERE WITHIN THE REQUIRED RANGE. ON (B)(6) 2025 THE INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY A FEW DAYS AFTER THE ECMO WAS COMPLETED. AS THE HLS SET HAD A LEAKAGE DURING TREATMENT AND THE INVOLVED PATIENT PASSED AWAY, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704585 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000430683 04058863078298

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Death