BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BE-HLS CANNULA 23F VL

    MDR report key: 4901252 · Received July 7, 2015

    Report

    Report Number
    8010762-2015-00791
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS REQUESTED THE PRODUCT IN QUESTION FOR EVALUATION BUT NOT YET RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF NEW INFO BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SENT ON 07/08/2015. THE MANUFACTURER RECEIVED THE PRODUCT IN QUESTION FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE PRODUCT IN QUESTION CRACKS ON THE 3/8 X 3/8 CONNECTOR ((B)(4)), ON THE SIDE OF THE FEM. INTRODUCER, WERE FOUND. THE TIGHTNESS TEST CONFIRMED THE LEAKAGE ON THE POSITION. ON THE OPPOSITE SIDE (CANNULA SIDE) THE CONNECTION BETWEEN THE CANNULA AND THE CONNECTOR WAS TIGHT. THE BLOOD WHICH HAD EMERGED DURING THE APPLICATION MOST LIKELY RAN FROM THE CONFIRMED LEAKAGE AIDE TOWARDS THE OPPOSITE SIDE OF THE CONNECTOR AND PASSED THROUGH THE MOLD SEPARATION OF THE CONNECTOR BETWEEN THE HOSE AND THE CONNECTOR. IN ADDITION A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED. DHR OF THE COMPLAINED LOT HAS BEEN REVIEWED AND NO ABNORMALITY WAS FOUND, ALSO, NO SCRAP RECORD WAS FOUND. BASED ON THE AVAILABLE INFORMATION THE MANUFACTURER CAN CONFIRM THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE FOR FINAL PACKAGING AND STERILIZATION. ACCORDING TO THE MANUFACTURER'S DATABASE, THIS WAS THE FIRST COMPLAINT RECEIVED FOR THE PRODUCT IN QUESTION, REGARDING THE CONFIRMED MALFUNCTION. THE DATA IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ECMO CONNECTION OF THE CANNULA TO THE HLS SET, IT WAS NOTICED THAT BLOOD WAS DRIPPING OUT OF THE CONNECTOR. THE VULNERABILITY IS LOCATED ON THE TRANSITION OF THE CANNULA TO THE CONNECTOR, ON THE CANNULA (BLOOD BETWEEN CONNECTOR AND CANNULA). THE CANNULA WAS REPLACED. NO CONSEQUENCES TO THE PT. ADDITIONAL INFO RECEIVED ON 06/15/2015. BLOOD LOSS MAX 10ML, NO PICTURES AVAILABLE; (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440161 BE-HLS CANNULA 23F VL DWF MAQUET CARDIOPULMONARY AG 70104.7295 92160034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention