BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 5973594 · Received September 23, 2016

    Report

    Report Number
    1219856-2016-00206
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 28, 2016
    Report Date
    August 29, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE POWER SUPPLY (P/N 77-0063-003, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF POWER SUPPLY WAS PERFORMED AND FOUND NO OBVIOUS DAMAGE OR DEFECTS. THE RECORDER STRIP WAS RETURNED FOR EVALUATION. THE POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND FUNCTIONAL TESTING WAS PERFORMED. THE PUMP WAS STARTUP AS NORMAL. THE YELLOW INDICATOR LED WAS ON WHILE RUNNING ON AC POWER AND NO BATTERY WARNING ALARM WAS NOTED. THE POWER CYCLE WAS PERFORMED MULTIPLE TIMES WITH NO ALARMS OR ERRORS. THE POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AUTOCAT2 SERIES SERVICE MANUAL (REV 3) AND ALL VOLTAGES WERE WITHIN SPECIFICATION; HOWEVER, THE POWER SUPPLY FAN WAS NOTED TO BE MALFUNCTIONED (WOULD NOT TURN ON WHILE AC POWER WAS PRESENT). THE PUMP WAS THEN LEFT TO RUN FOR OVER SIX HOURS WITH NO ALARMS OR ERRORS WERE OCCURRED. THE PUMP WAS RUN ON BATTERY (BATTERY LOAD TEST) UNTIL THE PUMP SHUT DOWN (>90MINUTES WITHIN SPEC). A BATTERY LOAD TEST WAS PERFORMED AFTER LETTING THE PUMP CHARGE FOR OVER 9 HOURS AND THE UNIT RAN ON BATTERY POWER FOR OVER 90 MINUTES ALONG WITH THE PROPER ALARMS "LESS THAN 20, 10, AND 5 MINUTES REMAINING". THE POWER SUPPLY PASSED BATTERY LOAD TEST. VISUAL INSPECTION OF POWER SUPPLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITY WAS FOUND BESIDE THE FAN MALFUNCTIONED. THE FAN WAS THEN REMOVED FROM THE POWER SUPPLY. THE FAN WAS FUNCTIONAL TESTED BY USING AN EXTERNAL POWER SUPPLY (12VDC). THE FAN WOULD NOT TURN ON WHEN 12VDC WAS APPLIED. NOTICE: WITHOUT A COOLING FAN, THE TEMPERATURE INSIDE THE POWER SUPPLY WOULD INCREASE OVERTIME AND THAT COULD AFFECT THE OUTPUTS TO BE UNSTABLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF "ALARM, SYSTEM ERROR 3" WAS CONFIRMED BY TELEFLEX (B)(4); HOWEVER, THE REPORTED ALARM COULD NOT BE REPLICATED DURING THE FUNCTIONAL TEST. THE FAN ON THE POWER SUPPLY WAS NOTED TO BE MALFUNCTIONING DURING TESTING. WITHOUT A COOLING FAN, THE TEMPERATURE INSIDE THE POWER SUPPLY WOULD INCREASE OVERTIME AND THAT COULD AFFECT THE OUTPUTS TO BE UNSTABLE. THE UNSTABLE OUTPUTS ON THE POWER SUPPLY MAY POTENTIALLY CAUSE THE REPORTED COMPLAINT. THE CAUSE OF THE FAN MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AFTER WORKING FOR 3 HOURS, THE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED "SYSTEM ERROR 3". THE ALARM SHOWED AGAIN AFTER REBOOT FOR 10 MINUTES. THE MD REPLACED WITH ANOTHER IABP. THE ENGINEER TOOK THE PUMP TO OFFICE. THE ENGINEER INSPECTED AND FOUND THE RADIATOR IN THE POWER BOX DIDN'T WORK. THE HEAT CAUSED CPU BOARD ABNORMAL. ENGINEER REPLACED THE POWER BOX ((B)(4)) AND MALFUNCTION WAS CONFIRMED. NO PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AFTER WORKING FOR 3 HOURS, THE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED "SYSTEM ERROR 3". THE ALARM SHOWED AGAIN AFTER REBOOT FOR 10 MINUTES. THE MD REPLACED WITH ANOTHER IABP. THE ENGINEER TOOK THE PUMP TO OFFICE. THE ENGINEER INSPECTED AND FOUND THE RADIATOR IN THE POWER BOX DIDN'T WORK. THE HEAT CAUSED CPU BOARD ABNORMAL. ENGINEER REPLACED THE POWER BOX (AR-77-0063-003) AND MALFUNCTION WAS CONFIRMED. NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625293 AUTOCAT 2 INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001110885

    Patients

    Seq Age Sex Outcome Treatment
    1