BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE MICRO HOLLOW FIBRE OXYGENATOR

    MDR report key: 167038 · Received April 29, 1998

    Report

    Report Number
    9611224-1998-00001
    Event Type
    Malfunction
    Date Received
    April 29, 1998
    Date of Event
    March 31, 1998
    Report Date
    April 1, 1998
    Manufacturer
    POLYSTAN A/S
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 980401 CO RECEIVED A COMPLAINT FROM A MICRO USER THAT DURING THE SET-UP OF TWO 014020 MICROS HAD EXPERIENCED THAT THE GAS INLET PRESSURE TO THE OXYGENATOR WAS EXTREMELY HIGH INDICATING A PARTIAL OR TOTAL BLOCKAGE WITH VERY LITTLE OR NO GAS BEING ABLE TO FLOW INTO AND THROUGH THE HOLLOW FIBRES. CO RECEIVED AND INVESTIGATED THE TWO MICROS AND CONFIRMED THAT THE HOLLOW FIBRE ENDS WERE BLOCKED WITH POLYURETHANE POTTING COMPOUND. CO IMMEDIATELY TESTED ADD'L MICROS WITH BOTH THE SAME AS WELL AS THE PREVIOUS AND FOLLOWING LOT #S AND THIS REVEALED BLOCKED FIBRE ENDS TO ONE DEGREE OR ANOTHER. A REVIEW OF THE PRODUCTION RECORDS FOR THESE THREE LOT #S INDICATED THAT ONE PARTICULAR ROLL OF HOLLOW FIBRE MAT MATERIAL WAS A COMMON FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE MICRO HOLLOW FIBRE OXYGENATOR BLOOD OXYGENATOR DTZ POLYSTAN A/S SAFE MICRO 980210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other CARDIOPULMONARY BYPASS CIRCUIT INCLUDING TUBING,| PUMPS ETC.