BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4562195 · Received February 27, 2015

    Report

    Report Number
    8010762-2015-00067
    Event Type
    Death
    Date Received
    February 27, 2015
    Date of Event
    January 30, 2015
    Report Date
    February 2, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE ANALYSIS OF ONE OF MAQUET'S THERAPY APPLICATION MANAGERS THE TIME WHEN AIR ENTERED IN THE PERFUSION SYSTEM WAS SIGNALLED ACOUSTICALLY AND VISUALLY AS WELL AS TRIGGERED THE ZERO FLOW MODE. THE VENOUS BUBBLE SENSOR WAS RESET 26:11 MINUTES LATER FOR UNKNOWN REASON. THE READ-OUT OF THE OFFLINE-DATA OF THE CARDIOHELP-I REPRESENTED A BEHAVIOR AS SPECIFIED. BUT THE CAUSE OF THE TIME INTERVAL OF 26:11 MINUTES FOR RESET OF THE VENOUS BUBBLE SENSOR AND THE AIR IN THE PERFUSION SYSTEM IS UNKNOWN BY CLINICAL SIDE DUE TO INSUFFICIENT INFORMATION. THEREFORE THE CARDIOHELP-I WORKED AS EXPECTED WHEN THE ZERO FLOW MODE WAS ACTIVATED DUE TO THE BUBBLE DETECTION. THEREFORE THE CLAIMED FAILURE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS NOT INVESTIGATED THE UNIT. THE PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT WILL BE PROVIDED BY MAQUET CARDIOPULMONARY AG. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT ECMO TREATMENT, A ZERO FLOW MODE ON THE CARDIOHELP-I WAS ACTIVATED DUE TO A HIGH PRIORITY ALARM APPEARING FOR NO OBVIOUS REASON. THE PT'S STERNUM WAS STILL OPEN AND THE SKIN CLOSED. THE DOCTOR OPENED THE SKIN AND A POOL OF BLOOD EXITED. THE PT'S HEART WAS MASSAGED AND A PERFUSIONIST WAS NOTIFIED. THE FLOW WAS RE-ESTABLISHED AND THE PT WAS TRANSPORTED TO THE OPERATING ROOM. THE PT EXPIRED A FEW DAYS LATER. ECMO - EXTRA CORPOREAL MEMBRANE OXYGENATION. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140779 CARDIOHELP SYSTEM CARDIOPULMONARY SUPPORT SYSTEM DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R