BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1934670 · Received November 24, 2010

    Report

    Report Number
    1219856-2010-00865
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CARDIOTHORACIC INTENSIVE CARE UNIT(CTICU), A MALE PT WAS RECEIVING INTRA-AORTIC BALLOON (IABP) THERAPY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED ON (B)(6) 2010 AT THE BEDSIDE AND THERAPY WAS DELIVERED FOR APPROXIMATELY 8 HOURS WITH NO PROBLEMS NOTED. THE INCIDENT OCCURRED WHEN THE RN CARING FOR THE PT TURNED THE PT ON HIS SIDE AND NOTICED BLOOD IN THE TUBING. THE IAB WAS TURNED OFF AND REMOVED. THE IAB WAS NOT REPLACED AND THE PT WAS LISTED AS "OK." THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS RELATED TO THIS EVENT. THE PT HAS BEEN TRANSFERRED OUT OF THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INTRA-AORTIC BALLOON PUMP