BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5227130 · Received November 16, 2015

    Report

    Report Number
    1219856-2015-00256
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE CONDOR POWER SUPPLY (P/N 77-0063-003, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF CONDOR POWER SUPPLY WAS PERFORMED AND FOUND NO OBVIOUS DAMAGE OR DEFECTS. THE CONDOR POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND FUNCTIONAL TESTING WAS PERFORMED. THE PUMP WAS STARTUP AS NORMAL. A POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AUTOCAT2 SERIES SERVICE MANUAL (REV 3) AND ALL VOLTAGES WERE WITHIN SPECIFICATION. THE PUMP WAS RUN ON BATTERY (BATTERY LOAD TEST) UNTIL THE IABP SHUT DOWN (>90MINUTES WITHIN SPEC). A BATTERY LOAD TEST WAS PERFORMED AFTER LETTING THE PUMP CHARGE FOR OVER 8 HOURS AND THE UNIT RAN FOR OVER 90 MINUTES. THE POWER SUPPLY PASSED ALL FUNCTIONAL TESTING. VISUAL INSPECTION OF CONDOR POWER SUPPLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITY WAS FOUND. OTHER REMARKS: 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 "LOST POWER DURING PATIENT TRANSPORT" IS NOT CONFIRMED. THE REPORTED PROBLEM COULD NOT DUPLICATE AT (B)(4) DURING THE FUNCTIONAL TEST. THE POWER SUPPLY PASSED FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PUMP LOST POWER DURING PATIENT TRANSPORT. PUMP QUICKLY SWITCHED OUT WITH ANOTHER. NO PATIENT IMPLICATIONS. FINDINGS/ACTION TAKEN: POWER SUPPLY SENT TO AND REPLACED BY BIOMED. BIOMED ALSO REPLACED THE BATTERY WITH A BATTERY OF EQUAL CAPACITY THAT THEY DID NOT OBTAIN FROM ARROW. ALSO, UMBILICAL CABLE NOT LOCKING IN PLACE, REPLACED. AC POWER CORD CLIP MISSING; REPLACED AND EXTRAS SENT. SCREWS ON RAISE LOWER MECHANISM BROKEN; REPLACED AND EXTRAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PUMP LOST POWER DURING PATIENT TRANSPORT. PUMP QUICKLY SWITCHED OUT WITH ANOTHER. NO PATIENT IMPLICATIONS. FINDINGS/ACTION TAKEN: POWER SUPPLY SENT TO AND REPLACED BY BIOMED. BIOMED ALSO REPLACED THE BATTERY WITH A BATTERY OF EQUAL CAPACITY THAT THEY DID NOT OBTAIN FROM ARROW. ALSO, UMBILICAL CABLE NOT LOCKING IN PLACE, REPLACED. AC POWER CORD CLIP MISSING; REPLACED AND EXTRAS SENT. SCREWS ON RAISE LOWER MECHANISM BROKEN; REPLACED AND EXTRAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755659 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0000911748

    Patients

    Seq Age Sex Outcome Treatment
    1