BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-TOP 23102 SCOTT & WHITE OR CPB PACK

    MDR report key: 4090126 · Received August 18, 2014

    Report

    Report Number
    2248146-2014-00292
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 5, 2012
    Report Date
    June 6, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE ACTUAL "LEAKING" PART WAS RETURNED FOR EVALUATION AND THE LEAKING JOINT WAS CONFIRMED. A REVIEW OF THE KIT DEVICE HISTORY RECORD REVEALED THAT THE KIT HAD BEEN BUILT TO DRAWING REVISION B, WHICH SPECIFIES THE USE OF 700005309 Y-PUMP CONNECTOR. USE OF THE 700005309 Y-PUMP CONNECTOR HAS BEEN DISCONTINUED BY THE MFR AND HAS SUBSEQUENTLY BEEN REPLACED WITH A NEW 7010523360 Y-PUMP CONNECTOR. (B)(4).

    Description of Event or Problem · 1

    WHEN THE CHIEF PERFUSIONIST WENT TO ADMINISTER CARDIOPLEGIA, THE PRESSURE WAS BETWEEN 300-310 MM HG AND THE CHIEF PERFUSIONIST NOTICED BLOOD LEAKING AT THE Y CONNECTOR. WHEN PRESSURE WAS REDUCED DOWN TO 250MM HG, THE LEAKING STOPPED, BUT AS SOON AS PRESSURE WENT ABOVE 250MM HG, IT WOULD LEAK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496311 BO-TOP 23102 SCOTT & WHITE OR CPB PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BO-TOP 23102 13398-05

    Patients

    Seq Age Sex Outcome Treatment
    1