BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7 FR - 30 CC

    MDR report key: 2080063 · Received April 7, 2011

    Report

    Report Number
    1219856-2011-00116
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL SUPPORT SPECIALIST (CSS) RECEIVED A CALL FROM THE CHARGE NURSE IN THE CARDIAC INTENSIVE CARE UNIT. THE INSERTION SITE WAS THE FEMORAL ARTERY. THE CHARGE NURSE (CN) DESCRIBED CONSTANT HELIUM LOSS ALARMS OCCURRING AT MINIMUM 5 TIMES. THE TUBING AND CONNECTIONS WERE CHECKED BY THE CN. THERE WAS NO VISIBLE BLOOD IN TUBING, NO KINKING AND THE PT IS NOT HAVING ANY ECTOPY. THE ALARM OCCURRED WITH THE SAME FREQUENCY WHEN PLACED IN 1:2 AND 1:4 ASSIST RATIO. THE PT'S HEART RATE IS 140 - 150'S. THE CSS CONFIRMED WITH THE CN THAT THERE IS NO BLOOD AND THE TUBING IS SECURE. THE CN STATED THAT THEY HAD "CHECKED EVERYTHING THEY KNEW TO LOOK AT." THEY ALSO CHANGED PUMPS TO ENSURE IT WAS NOT AN INTRA-AORTIC BALLOON PUMP (IABP) ISSUE. THE CSS EXPLAINED THAT THIS WAS A PROBABLE INTRA-AORTIC BALLOON (IAB) RUPTURE DUE TO THE FREQUENCY OF THE ALARM AND THAT IT CONTINUED TO OCCUR IN 1:2 AND 1:4 ASSIST. THE CSS THEN SPOKE WITH THE RN WHO WAS TAKING CARE OF THE PT. HE WAS GOING TO HAVE THE FELLOW COME IN AND REPLACE THE CATHETER, SAVING THE IAB FOR RETURN. ADDITIONAL INFO WAS RECEIVED AT 0926 EST BY THE RN FROM THE HOTLINE AGAIN. WHEN THE CSS CALLED BACK, THEY HAD CHANGED THE HELIUM TUBING AND THE ALARM HAD STOPPED. THE RN STATED THAT THE ECHO TECH HAD BEEN IN THE ROOM PERFORMING THE ECHO AND AFTER HE WAS IN, THE ALARMS STARTED. THE RN WANTED TO F/U AND LET US KNOW THERE WILL BE NO IAB FOR RETURN. THE PUMP CURRENTLY IS PUMPING WITH NO ALARMS WITH THE NEW DRIVELINE TUBING. IT WAS NOTED THAT THE PUMP WAS AN IAP-0500, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF0118555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK