BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5844228 · Received August 3, 2016

    Report

    Report Number
    1219856-2016-00171
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE FRONT END BOARD (P/N: 77-1010-002 S/N: (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF FE BOARD WAS PERFORMED AND A BURNT CAPACITOR C202 WAS FOUND. THE BURNT COMPONENT C202 WAS CAUSED A SHORT CIRCUIT (-12 VOLTS TO GROUND). NO FURTHER FUNCTIONAL TESTING CAN BE PERFORMED ON THE FRONT END BOARD DUE TO THE DAMAGE COMPONENT C202 (-12 VOLTS CIRCUITRY). NO FURTHER TESTING CAN BE PERFORMED DUE TO A SHORT ON THE CIRCUITRY. 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 1" IS CONFIRMED. A BURNT COMPONENT C202 WAS FOUND ON THE FEB AND THAT CAUSED A SHORT IN THE CIRCUIT. THE BURNT COMPONENT WAS THE CAUSE OF THE REPORTED COMPLAINT; HOWEVER, THE ROOT CAUSE OF THE BURNT COMPONENT C202 IS UNDETERMINED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PUMP HAD SYSTEM ERROR #1 ALARMS AND STOPPED PUMPING WHILE ON PATIENT. PUMP SWITCHED OUT QUICKLY. NO PATIENT COMPLICATIONS. FINDINGS / ACTIONS TAKEN: REPLACED FRONT END BOARD. SOFTWARE LEVEL: (B)(4). EXPEDITED QA REVIEW: YES. CONFIRMED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PUMP HAD SYSTEM ERROR #1 ALARMS AND STOPPED PUMPING WHILE ON PATIENT. PUMP SWITCHED OUT QUICKLY. NO PATIENT COMPLICATIONS. FINDINGS / ACTIONS TAKEN: REPLACED FRONT END BOARD. SOFTWARE LEVEL: 2.24. EXPEDITED QA REVIEW: YES. CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495458 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1