BEUDAMED
    FDA Adverse Event Death Summary report: N

    BE-HLS CANNULA 19F AS

    MDR report key: 4897930 · Received July 6, 2015

    Report

    Report Number
    8010762-2015-00786
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    January 15, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR COULD NOT OBTAIN THE PRODUCT IN QUESTION OR THE LOT NUMBER OF THE PRODUCT. THE MFR HAS NOT RECEIVED INFO OF SIMILAR INCIDENTS IN REGARDS TO THE PRODUCT IN QUESTION AND THE ACCESSORY SKIN FIXATION. A CLINICAL EVAL OF THE AVAILABLE INFO WAS PERFORMED AND BASED ON THE INFO AVAILABLE TO THE MFR AT THIS TIME, THERE IS NO INDICATION THAT THE HLS CANNULA OR THE ACCESSORY SKIN FIXATION HAS BEEN FLAWED. R&D WAS INFORMED OF THE CUSTOMERS SUGGESTION TO REWORK THE IFU WITH COMPLEMENTAL INFO ON THE SKIN FIXATION. R&D WILL EXAMINE ALL AVAILABLE INFO TO CONSIDER POSSIBLE CHANGES TO THE IFU FOR ENHANCED CUSTOMER SATISFACTION. BASED ON THE INFO AVAILABLE TO THE MFR AT THIS TIME A MALFUNCTION OF THE PRODUCT IN QUESTION CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 IT CAME TO BE KNOWN THAT THERE WAS A DISLOCATION OF AN ARTERIAL ECMO CANNULA, WHICH WAS PLACED PERCUTANEOUSLY ON (B)(6) 2015. THE PT EVENTUALLY EXPIRED IN THE FURTHER COURSE, ALTHOUGH THE CAUSE OF DEATH IS NOT CLEARLY RELATED TO THE DISLOCATION. THIS EVENT WAS REPORTED TO THE SWISS AUTHORITY BY THE MEDICAL MANAGEMENT AND IS UNDER OFFICIAL INVESTIGATION. THE CANNULA WAS INSERTED AND POSITIONED WITHOUT ANY PROBLEM AND FIXATED IN ACCORDANCE WITH THE ENCLOSED INSTRUCTIONS FOR USE, USING THE HOLDER PROVIDED FOR THIS PURPOSE AND FIXATED TO THE SKIN. THE TIGHT FIT WAS CHECKED BY THE SURGEON AS WELL AS THE PERFUSIONIST. THE DISLOCATION TOOK PLACE INSIDIOUSLY AND WAS NOTICED ON THE NEXT DAY DURING THE NIGHT. THE PRODUCT IS NOT AVAILABLE FOR EVAL. THE TREATMENT WAS A VENOUS-ARTERIAL PROCEDURE AND THE PRODUCT IN QUESTION WAS PLACED FEMORALLY. BECAUSE OF THE ONGOING LEGAL INVESTIGATION, THE PERFUSION PROTOCOL AS WELL AS FURTHER EVENT RECORDING IS INACCESSIBLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435050 BE-HLS CANNULA 19F AS DWF MAQUET CARDIOPULMONARY AG 70104.7282

    Patients

    Seq Age Sex Outcome Treatment
    1 Death