BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP-I

    MDR report key: 5980138 · Received September 27, 2016

    Report

    Report Number
    8010762-2016-00599
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 12, 2016
    Report Date
    August 28, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REF EXEMPTION # (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    08/28/2017 11:30 AM (GMT-4:00) ADDED BY (B)(6): NO INVESTIGATION BY FIELD SERVICE TECHNICIAN, AS THE CUSTOMER SERVICES THEIR DEVICES, THEREFORE NO SERVICE ORDER AND NO FURTHER INFORMATION AVAILABLE FOR THIS CASE. THE DEVICE IS BACK IN USE AND THE CUSTOMER REPLACED NO PARTS. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED OCTOBER 20,2016. THE HOSPITAL SUBMITTED A FACILITY MEDWATCH REPORT UF/IMPORTER/REPORT # 0300020000-2016-8003. PATIENT WAS ON ECMO MACHINE FOR SEVERAL DAYS. THE ECMO (CARDIOHELP) CIRCUIT SCREEN WENT BLACK, PATIENT WAS BAGGED AND PRESSORS STARTED. EPINEPHRINE GIVEN WHILE THE ECMO SPECIALIST STARTED TO HAND CRANK THE ECMO CIRCUIT. ATTEMPTS TO TURN ON THE CARDIOHELP FAILED. MACHINE / CIRCUIT SWITCHED OUT. THE PATIENT CODED DURING THIS TIME AND SURVIVED. INTERNAL REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING PATIENT TREATMENT THE SCREEN WENT BLANK AND A HIGH PITCHED NOISE WAS COMING FROM THE MACHINE. THE PATIENT STARTED TO DESATURATE. THEY WERE NOT GETTING ANY FLOW FROM THE CIRCUIT AND WITH THE PATIENT DECOMPENSATING THEY STARTED TO HAND CRANK. THE NURSE WAS ABLE TO HAND CRANK, UNTIL THEY COULD TRANSFER THE PATIENT TO ANOTHER UNIT. NO NEGATIVE CONSEQUENCES FOR THE PATIENT WERE REPORTED. (B)(4).

    Description of Event or Problem · 1

    INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633682 CARDIOHELP-I TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG 701048012

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R