BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 1133067 · Received August 22, 2008

    Report

    Report Number
    1219856-2008-00400
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    December 28, 2007
    Report Date
    August 22, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IT IS REPORTABLE. EVAL: THE INTRA-AORTIC BALLOON (IAB) WAS NOT RETURNED. TWO 6" ARTERIAL PRESSURE (AP) LINES WERE RETURNED. THERE WAS BLOOD ON THE RETURNED AP LINE. AFTER BLOCKING ALL OPENINGS ON EACH STOPCOCK, WATER WAS INJECTED INTO IT. ON BOTH SAMPLES A LEAK WAS EVIDENT WHERE THE 6" TUBING CONNECTS TO THE STOPCOCK. THE PARTS WERE EXAMINED UNDER MAGNIFICATION & A VOID IN THE SOLVENT WAS DETECTED AT THE STOPCOCK/TUBING JUNCTION. A DHR RE-REVIEW WAS CONDUCTED ON THE IAB & IT MET ALL SPECIFICATIONS & PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN THE DHR & THE REPORTED COMPLAINT. THE POTENTIAL CAUSE OF THIS ISSUE IS MANUFACTURING RELATED SINCE THE BONDING AT THE STOPCOCK/TUBING JUNCTION APPEARED TO BE INCOMPLETE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "6 INCH PRESSURE TUBING WITH STOPCOCK" WAS FOUND DEFECTIVE PRIOR TO USE. THE STAFF NOTICED A LEAK AT THE JUNCTION OF THE PRESSURE TUBING AND STOPCOCK. AS A RESULT, THE TUBING WAS REPLACED. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF7086555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK