BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED

    MDR report key: 11594592 · Received March 31, 2021

    Report

    Report Number
    8010762-2021-00222
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE MANUFACTURER IS STILL PENDING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT 1-2 HOURS AFTER INITIALIZING SUPPORT, THE INTERNAL PRESSURE SENSOR BEGAN RECORDING A NEGATIVE VALUE AND BEGAN RECORDING VARIABLE NEGATIVE VALUES AND TRIGGERING ALARMS THAT COULD NOT BE SILENCED. THE PRODUCT WAS EXCHANGED. THE PRODUCT WAS NOT AVAILABLE FOR A TECHNICAL INVESTIGATION AT THE LABORATORY OF THE MANUFACTURER. THUS A REVIEW FOR A SIMILAR COMPLAINT WITH A PERFORMED LABORATORY INVESTIGATION WAS PERFORMED. NO SIMILAR COMPLAINT WITH A TECHNICALLY CONFIRMED ROOT CAUSE INVESTIGATION WAS FOUND. THE PRODUCTION RECORDS OF THE AFFECTED HLS MODULE (DMS# 2950488, 2977717) WERE REVIEWED ON 2021-04-07. FOLLOWING TESTS ARE PERFORMED ACCORDING TO THE BOP AS A 100 % INSPECTION: GLUING OF SENSORS, GLUING OF COVER FOR TEMPERATURE AND PRESSURE SENSOR, FUNCTIONALITY TEST HLS MODULE (SENSORS AND PUMP). ACCORDING TO THE FINAL TEST RESULTS, THE OXYGENATOR WITH THE SERIAL# (B)(4) PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME AND THE FACT THAT THE PRODUCT WAS NOT AVAILABLE FOR TECHNICAL INVESTIGATION IT WAS NOT POSSIBLE TO DETERMINE AN EXACT ROOT CAUSE OF THE REPORTED EVENT. MOST PROBABLE ISSUES WITH THE PRESSURE TRANSDUCER (CALIBRATION, HUMIDITY, FUNCTIONALITY) COULD HAVE LED TO THE MALFUNCTION OF THE INTERNAL PRESSURE SENSOR (WITH REFERENCE TO IFU (INSTRUCTION FOR USE) CARDIOHELP SYSTEM 1.8 / EN / 09, 9.3.3). THUS THE REPORTED FAILURE COULD BE CONFIRMED. THE OCCURRENCE RATE REGARDING THE ABOVE COMPLAINT IS BELOW THE ACCEPTANCE RATE. THUS, NO REMEDIAL ACTION 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.

    Description of Event or Problem · 1

    ECLS (EXTRA CORPOREAL LIFE SUPPORT) VENO - VENOUS SUPPORT CASE UTILIZING 7.0 HLS KIT. THE CIRCUIT WAS PRIMED PROPERLY PER IFU (INSTRUCTION FOR USE) INSTRUCTIONS. PRESSURE SENSORS WERE "ZEROED" PRIOR TO PRIMING THE CIRCUIT. 1-2 HOURS AFTER INITIALIZING SUPPORT, THE INTERNAL PRESSURE BEGAN RECORDING A NEGATIVE VALUE AND BEGAN RECORDING VARIABLE NEGATIVE VALUES AND TRIGGERING ALARMS THAT COULD NOT BE SILENCED. THE INTERNAL SENSOR CABLE WAS CHECKED AND WAS IN PROPER POSITION THE PUMP FLOW AND RPM (ROTATIONS PER MINUTE) REQUIREMENT TO ACHIEVE FLOW WAS APPROPRIATE, AND THE GAS EXCHANGE WAS REPORTED PER CLINICIAN AS NOT COMPROMISED. NO VISIBLE SIGNS OF THROMBUS FORMATION WERE NOTED. THE CLINICIANS DECIDED TO REPLACE THE CIRCUIT DUE TO INCONSISTENT PRESSURE VALUES AND ALARMS. THE CIRCUIT IS NOT AVAILABLE AS THIS IS A COVID-19 PATIENT. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 1

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495239 HLS SET ADVANCED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS-7050 70138158

    Patients

    Seq Age Sex Outcome Treatment
    1