BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX

    MDR report key: 1842135 · Received August 11, 2010

    Report

    Report Number
    1842135
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD GONE IN FOR OPEN HEART SURGERY WITH BALLOON ALREADY INSERTED VIA THE LEFT GROIN. WHEN THE PATIENT CAME BACK FROM THE OR THE ARTERIAL LINE THAT IS DIRECTLY CONNECTED TO THE BALLOON HAD BEEN BROKEN OFF. STAFF WAS UNABLE TO TELL HOW LONG THAT THE LINE HAD BEEN BROKEN. STAFF REMOVED THE BROKE TUBING AND WERE UNABLE TO DRAW BACK BLOOD AND THE LINE WOULD ALSO NOT FLUSH. BALLOON WAS REMOVED PER PROTOCOL AND IT WAS NOTED THAT A CLOT HAD FORMED AT THE END OF THE BALLOON. IT IS STAFFS OPINION THAT THE LINE WAS BROKEN DURING TRANSFER TO/FROM THE OR TABLE. BALLOON HAS BEEN SENT TO MANUFACTURER FOR EVALUATION.HEALTH PROFESSIONAL'S IMPRESSION: IT IS STAFFS OPINION THAT THE LINE WAS BROKEN DURING TRANSFER TO/FROM THE OR TABLE. BALLOON HAS BEEN SENT TO MANUFACTURER FOR EVALUATION.MANUFACTURER RESPONSE FOR CATHETER, INTRA-AORTIC BALLOON, FIBEROPTIX: MANUFACTURER PROVIDED RGA# FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIX CATHETER, INTRA-AORTIC BALLOON DSP ARROW INTERNATIONAL 40CC FIBEROPTIXS 8FR *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR