BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL CLEAR CUFF (MATKON 145975)

    MDR report key: 1642612 · Received March 24, 2010

    Report

    Report Number
    MW5015282
    Event Type
    Injury
    Date Received
    March 24, 2010
    Date of Event
    January 15, 2010
    Report Date
    March 17, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    KZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, IABP PLACED IN CVL VIA LEFT FEMORAL ACCESS WITHOUT COMPLICATION. ON (B) (6) 2010, PRESSURE INFUSOR BAG LOST PRESSURE DURING THE NIGHT RESULTING IN THE CLOTTING OF THE INNER LUMEN OF THE IABP CATHETER. UNABLE TO CLEAR CATHETER, INABILITY TO MONITOR PRESSURE OR TIME IABP CORRECTLY DUE TO THIS . PT BROUGHT TO CVL FOR REPLACEMENT OF IABP CATHETER, NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL CLEAR CUFF (MATKON 145975) INFUSOR BAG KZD SMITHS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DATASCOPE IABP DEVICE| DATASCOPE IABP CATHETER 50CC