BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 10974839 · Received December 9, 2020

    Report

    Report Number
    8010762-2020-00428
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 23, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION RECORDS OF THE AFFECTED HLS MODULE WERE REVIEWED ON 2020-12-23. ACCORDING TO THE FINAL TEST RESULTS DURING AND AFTER PRODUCTION, ALL OXYGENATORS PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. A REVIEW FOR COMPLAINTS WITH SIMILAR REPORTED FAILURES WAS PERFORMED AND THE COMPLAINTS # 240775 AND # 282763 WERE FOUND. AS STATED IN THE CORRESPONDING INVESTIGATIONS FOLLOWING MOST PROBABLE ROOT CAUSES COULD BE DETERMINED: -INTERNAL SENSORS GOT WET AND THEREFORE MEASURED FAULTY PRESSURES -PRESSURE CONNECTOR CORRODED (E.G. DUE TO PRIMING FLUID) BASED ON THIS THE FAILURE COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE 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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4) NOTE: THE INVOLVED CARDIOHELP UNIT WAS REPORTED UNDER EMDR #396408 (8010762-2020-00402) AND EMDR FOLLOW UP #397227. FURTHER THE ISSUE WAS REPORTED UNDER MW5098085.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER STATED THE PUMP HAD PINT READING OF 500 BUT THEY DID NOT BELIEVE THIS TO BE ACCURATE. IN ORDER TO STOP THE ALARM FROM GOING OFF THEY REZEROED THE PRESSURE. A FEW HOURS LATER THE PVEN READING WENT TO -700 AND STOPPED THE PUMP. THEY EMERGENTLY SWAPPED OUT CARDIOHELP MACHINES AND RESUMED PATIENT SUPPORT. HOWEVER, AFTER A FEW HOURS THE ISSUE RETURNED AND PERSISTED LEADING THEM TO BELIEVE IT WAS POSSIBLY THE HLS SET. COMPLAITN ID:(B)(4). NOTE: THE CARDIOHELP WAS REPORTED UNDER COMPLAINT ID (B)(4), EMDR#396408 (MFG REPORT NUMBER. 8010762-2020-00402). THE ISSUE WAS ALSO REPORTED TO THE FDA UNDER MW5098085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444292 HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

    Patients

    Seq Age Sex Outcome Treatment
    1