BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010762-2019-00063

    MDR report key: 8400727 · Received March 7, 2019

    Report

    Report Number
    8010762-2019-00063
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 5, 2019
    Report Date
    March 7, 2019
    PMA / PMN Number
    K100278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). MAQUET (B)(4) REQUESTED THE PRODUCT FOR INVESTIGATION IN THE LABORATORY OF THE MANUFACTURER. AS STATED ON 2019-02-14 BY THE CUSTOMER "ALL THE OXYGENATORS WERE THROWN OUT" THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED BY THE MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED ALREADY WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. ACCORDING TO THE STATEMENT OF THE CUSTOMER FROM 2019-02-10 "WE KNOW IT¿S THE PATIENT. WE KNOW IT¿S NOT THE OXYS" AND FROM 2019-02-14 "I THREW IT OUT AS IT WAS USER ERROR". BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    INITIAL COMPLAINT: THE OXYGENATOR WAS FUNCTIONING APPROPRIATELY BUT AROUND 07:00 THE SAME DAY, THE TRANSMEMBRANE PRESSURES INCREASE AGAIN FROM 10 MMHG TO 40MMHG. WE ELECTED TO KEEP AN EYE ON IT AND MADE A PLAN IF IT SHOULD HAVE FAIL. THE PRESSURES INCREASED TO 120MMHG. WE HAD A DISCUSSION WITH THE PHYSICIAN TEAM FOR DIRECTION AND THE MANUFACTURER WAS CALLED. THE PHYSICIAN TEAM AND I AGREED TO CHANGING THE OXYGENATOR WHEN THE TRANSMEMBRANE PRESSURE REACHED 150MM OR THE HEMOLYSIS LEVEL WAS 120 (PLASMA FREE) AND TO START WEANING THE PATIENT OFF ECMO SUPPORT. ON (B)(6) 2019 17:05. WE ELECTED TO CHANGING THE OXYGENATOR DUE TO INABILITY TO MAINTAIN ECMO BLOOD FLOW AND TRANSMEMBRANE PRESSURES OF 150MMHG. ACCORDING TO THE INITIAL COMPLAINT REPORT OF (B)(4) THREE OXY´S WERE INVOLVED IN THE INCIDENT. FIRST ONE - (B)(4). SECOND ONE - (B)(4) AND THE THIRD ONE WILL BE HANDLED IN COMPLAINT (B)(4). THE THIRD ONE WAS ALSO REPLACED DURING THE PROCEDURE WITH AN ADULT OXY. NO HARM TO THE PATIENT WAS REPORTED. ALL HAD AN INCREASE IN TRANSMEMBRANE PRESSURE . (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention