BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 4249895 · Received November 6, 2014

    Report

    Report Number
    1219856-2014-00207
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 26, 2014
    Report Date
    October 26, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC CARE UNIT RN CALLED THE CLINICAL SUPPORT SPECIALIST (CSS) ON (B)(6) 2014 AT 0140 EST DUE TO A DRAIN FAILURE ALARM THAT OCCURRED ONCE. HRR (HEART RATE AND RHYTHM), NSR (NORMAL SINUS RHYTHM) 90-100'S. THE CSS ASKED THE RN IF THERE WAS ANY VISIBLE FLUID IN THE HELIUM DRIVELINE AND THE RN CONFIRMED THERE WAS NOT. THE CSS EXPLAINED TO THE RN THE POSSIBLE REASONING FOR THE ALARM AND REASSURED THE RN IT WAS NOT CAUSING HARM TO THE PT. THE CSS THEN EXPLAINED TO THE RN THAT IF THE ALARM RECURRED IN APPROX 20 MINUTES, MORE THAN ONE TIME (EVERY 20 MIN) THERE COULD BE A VALVE ISSUE AND THE INTRA-AORTIC BALLOON PUMP (AUITOCAT2WAVE, S/N (B)(4)) WOULD NEED TO BE SENT TO BIOMED TO BE CHECKED WHEN REMOVED FROM THE PT. AFTER MUCH DISCUSSION, THE CSS AND RN PERFORMED A MANUAL PURGE TO ALLEVIATE THE RN'S CONCERNS AND CONFUSION. THE RN HAD NO FURTHER QUESTIONS AT THIS TIME. AT 0524 EST, THE RN CALLED BACK AND THE CSS COULD HEAR THE PUMP ALARMING AND NOT PUMPING OVER THE PHONE. THE RN STATED THERE WAS BLOOD COMING BACK TO THE PUMP. THE CSS HAD TO RN RESET THE ALARM TO SILENCE IT AND THEN HAD THE RN CLAMP THE TUBING. THE RN CONFIRMED THE BLOOD HAD NOT REACHED BACK TO THE PUMP AND WAS JUST IN THE TUBING. THE RN SAID THE ALARM JUST HAPPENED AND THEY SAW THE BLOOD COME IN THE LAST COUPLE OF MINUTES. THE CSS TOLD THE RN THE INTRA-AORTIC BALLOON (IAB) WAS RUPTURED AND IT NEEDED TO BE REMOVED WITHIN 30 MINUTES. A FELLOW WAS AT BEDSIDE AND WAS GOING TO CALL THE ATTENDING DOCTOR TO DISCUSS. THE CSS ASKED THE RN WHAT THE ALARM WAS AND THE RN SAID THERE WAS NO ALARM. THE CSS EXPLAINED THAT AAS SHE HAD INSTRUCTED THE RN TO SILENCE (RESET) THE ALARM WHEN THE CSS ANSWERED THE PHONE, THERE WAS AN ALARM. THE RN COULD NOT TELL THE CSS WHAT THE ALARM SAID, HOWEVER ONE OF THE RN'S COLLEAGUES STATED "SOMETHING ABOUT A KINKED CATHETER." THE CSS THEN ASKED THE RN IF IT HAD SAID HELIUM LOSS OF HIGH PRESSURE AND THE COLLEAGUE ANSWERED HIGH PRESSURE. THE CSS THEN ASKED THE RN TO SAVE THE IAB ONCE REMOVED AND TO CALL THE CSS BACK AFTERWARDS TO FOLLOW UP. AT 0730 EST, THE RN CALLED BACK AND CONFIRMED THE DOCTOR HAD COME IN AND REMOVED THE IAB WITHOUT INCIDENCE. THE PT WAS STABLE WITHOUT THE IAB AND THEREFORE, THE DOCTOR HAD DECIDED NOT TO INSERT ANOTHER IAB. PUMP STRIPS WERE GENERATED. THERE IS NO X-RAY FOR REVIEW. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN INDEFINITE DELAY IN THERAPY WHICH DID NOT CAUSE HARM TO THE PT. THE PT OUTCOME IS UNCHANGED THROUGHOUT BOTH CALLS. IT WAS NOTED THAT THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED. THE PUMP WILL NOT BE SEND TO BIOMED AS IT DID FUNCTION APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714819 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1