BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 2013775 · Received February 4, 2011

    Report

    Report Number
    1219856-2011-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED ON (B)(6 2011. THREE DAYS LATER, WHILE IN THE CARDIOLOGY INTENSIVE CARE UNIT, BLOOD APPEARED IN THE HELIUM TUBING. IT WAS REPORTED THAT "THE BLADDER BECAME POROUS." THERE WAS NO REPORTED PATIENT DEATH OR INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE QA ASSISTANT ON (B)(6 2011,INDICATED THAT THE IAB WAS PREPPED PER THE INSTRUCTIONS FOR USE. ANOTHER IAB WAS NOT USED AS THE PATIENT WAS SELF-SUFFICIENT, SO NO MORE COUNTERPULSATION THERAPY WAS NEEDED. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0063503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK