BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 2860022 · Received December 4, 2012

    Report

    Report Number
    1219856-2012-00343
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PATIENT THAT EXPIRED WHILE IN THE INTENSIVE CARE UNIT. DATE OF PATIENT DEATH: (B)(6) 2012 AT 6:00 AM, SOON AFTER REMOVAL OF THE INTRA-AORTIC BALLOON (IAB). RELATION BETWEEN THE PRODUCT AND CAUSE OF DEATH: NONE. INDICATION FOR USE: PATIENT USED DEMAND PACEMAKER. HEART RATE: 90 APPROX 110. THE CORONARY ARTERY RUPTURED AND CARDIAC TAMPONADE HAPPENED WHILE THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS DONE, SO THE PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS USED AND THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED. ON (B)(6) 2012 THE MEDICAL DOCTOR INSERTED THE IAB THROUGH THE TEFLON SHEATH VIA LEFT FEMORAL ARTERY WITH NO ISSUES. THE PUMP WAS SET TO ZERO AND THE PUMPING WAS INITIATED. APPROXIMATELY 5 HOURS LATER THE TRIGGER MODE WAS SWITCHED TO PATTERN AND AFIB. HOWEVER, THE ECG WAVEFORM ON THE PUMP SCREEN WAS NOT SHOWING PROPERLY. THE MAIN POWER SUPPLY WAS CONNECTED. THERE WAS NO PROBLEM SEEN USING THE FIBEROPTIX SENSOR (FOS). THE PUMP SUDDENLY STOPPED WITHOUT THE ALARM GOING OFF. AS A RESULT, THE USER TURNED THE MAIN POWER OFF THEN BACK ON, BUT THE PUMP STOPPED AGAIN AFTER ROUGHLY 1 MINUTE. THE USER TURNED THE MAIN POWER OFF THEN BACK ON AGAIN AND THE PUMP WAS USED UNTIL THE IAB WAS REMOVED WITHOUT ISSUES. THERE WAS NO REPORT OF PATIENT COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. THE PATIENT EXPIRED; HOWEVER, IT HAS BEEN STATED FROM THE MEDICAL ENGINEER THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE PUMP WILL BE INVESTIGATED. THE IAB SAMPLE WAS DISCARDED BECAUSE THE USER FOUND NO RELATION BETWEEN THE IAB AND PATIENT'S DEATH. ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT STATED: ON (B)(6) 2012, 12:48 PM, CORONARY ARTERY RUPTURED AND CARDIAC TAMPONADE HAPPENED. AT 13:59 PM, INSERTION OF IAB. MIDNIGHT BLOOD PRESSURE LOWERED DOWN TO 20 APPROXIMATELY 30MMHG. ON (B)(6) 2012, 06:00 AM, PATIENT PASSED AWAY SOON AFTER THE IAB WAS REMOVED. IT WAS NOTED THAT MESSAGE WAS TOLD TO THE PATIENT'S FAMILY THAT THE OUTCOME OF THE REMOVAL OF IAB WILL LEAD TO DEATH BUT THE FAMILY DID NOT REQUEST FOR FURTHER LIFE PROLONGING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death