BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 3851774 · Received April 22, 2014

    Report

    Report Number
    1219856-2014-00078
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K002256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL FROM THE CARDIAC INTENSIVE CARE UNIT RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) ON (B)(6) 2014 AT 1618 (B)(6) THAT THE RN WAS CALLING BECAUSE THEY WERE GETTING LOW HE (HELIUM) TANK PRESSURE ALARMS. THEY HAVE CHANGED THE TANK THREE TIMES AND CONTINUE TO GET THE SAME ALARMS. THE CSS VERIFIED THE ACTUAL ALARM MESSAGE AS LOW HE TANK PRESSURE (NOT HE LOSS). THERE WAS NO DISPLAY IN THE TANK GAUGE RED OR BLUE. THE CSS HAD THEM CHECK THE VALVE ON TOP OF THE TANK. DURING THE CONVERSATION THEY WERE ALREADY SWITCHING THE IAP-0400 OUT. THE SECOND PUMP WORKED WITHOUT ISSUE. AT 1723 THE CSS CALLED THE RN BACK. THE PATIENT HAD STABILIZED AND WAS SUPPORTED ON THE PUMP. THE RN FELT THERE WAS A 5 MINUTE OR LESS DELAY IN THERAPY, AS THIS PROCESS STARTED PRIOR TO THE INTRA-AORTIC BALLOON (IAB) BEING INSERTED THROUGH THE SHEATH VIA FEMORAL WITHOUT ISSUE. THERE HAVE BEEN NO OTHER ALARMS AND THE PUMP IS ACHIEVING THE GOALS OF THERAPY. THE RN THOUGHT THAT THE VALVE ON TOP OF THE TANK WAS OPEN, BUT IS NOT 100 PERCENT SURE. THE OTHER PUMP WAS TAGGED TO GO TO BIOMED TO BE CHECKED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS THE PATIENT IS CURRENTLY BEING SUPPORTED ON INTRA-AORTIC BALLOON PUMP (IABP) THERAPY AS PLANNED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 PER FIELD SERVICE REPORT. SYMPTOM: LOW HELIUM ALARM. THE PUMP WAS SENT TO BIOMED. FINDINGS/ACTION TAKEN: BIOMED REPLACED HELIUM WASHER AND REINSERTED HELIUM TANK. A PRESSURE TEST AND LEAK TEST WERE PERFORMED. THE CONSOLE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243585 AUTOCAT 2 INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1