BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR -40 CC FOS

    MDR report key: 1895508 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00795
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A PHONE CALL FROM THE RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) THAT "THERE IS BLOOD IN THE HELIUM DRIVE TUBING." THE CSS CONFIRMED THAT IT WAS THE HELIUM DRIVE TUBING AND NOT THE CENTRAL LUMEN (BIGGER TUBE). THE RN DID CONFIRM THIS. THE RN SAID THERE WERE A COUPLE OF DROPS THAT WERE FLUCTUATING ON THE TUBING WALL WITH THE MOVEMENT OF THE HELIUM. THE CSS RELAYED THAT "DUE TO THE BLOOD IN THE TUBING, WE RECOMMENDED THAT THE IAB BE REMOVED AS THIS INDICATES A RUPTURED INTRA-AORTIC BALLOON (IAB)." THE MD WAS ALREADY AWARE OF THE BLOOD IN THE LINE. THE CSS RECEIVED NO FURTHER CALLS ON (B)(6) 2010. AT 1140 EST (B)(6) 2010 THE CSS CALLED THE UNIT AND SPOKE TO THE CHARGE RN WHO STATED THAT THE IAB WAS NOT EXCHANGED AND THE BLOOD WAS STILL PRESENT. THE CSS AGAIN RELAYED THAT THE "IAB SHOULD BE REMOVED DUE TO PROBABLE RUPTURE." PER THE RN, "THE PT MAY BE GOING BACK TO SURGERY FOR BLEEDING COMPLICATIONS UNRELATED TO THE IAB." THE RN RELAYED THAT THE MD HAS BEEN NOTIFIED OF THE BLOOD IN THE LINE. THERE WAS NO REPORTED PT DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. ADD'L INFO RECEIVED FROM THE SALES REP ON (B)(6) 2010 STATED "I MET WITH THE ACCOUNT YESTERDAY AND HAVE MORE INFO. THE IAB WAS REMOVED AND REPLACED ON (B)(6) AFTER CSS'S 2ND CONVERSATION WITH THEM AND RECOMMENDATION. THERE WAS WHAT APPEARED TO BE A CLOT ON THE IAB AND THE PT DID SUSTAIN SOME ARTERIAL DAMAGE UPON REMOVAL. THEY SAVED THE IAB, BUT BIOMED WAS STILL LOOKING AT IT AND NOT READY TO RELEASE IT TO ME YET. THEY WILL IN THE NEXT FEW DAYS. BIOMED'S INITIAL REPORT WAS THAT NO BLOOD HAD MADE IT BACK TO THE PUMP. I DON'T KNOW IF THEY HAD ANY OTHER FINDINGS ON THE PUMP, BUT THEY DID INDICATE THE ABRASION LOOKED "SMALL" AND THERE WAS A SLIGHT AMOUNT OF BLOOD IN THE DRIVELINE TUBING."

    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 INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other