BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5806303 · Received July 19, 2016

    Report

    Report Number
    1219856-2016-00170
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 1, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE I/O BOARD (P/N 77-1100-001, (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE I/O BOARD WAS PERFORMED AND NO ABNORMALITIES WERE NOTED. THE I/O BOARD WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND THE IABP WAS POWERED ON. NO STATIC ARTERIAL PRESSURE (AP) PRESSURE ON TRANSDUCER LINE WAS NOTED WHILE IN AUTO MODE. THE INTRA-AORTIC BALLOON PUMP (IABP) WAS THEN LEFT ON FOR AN HOUR IN THE INITIAL POWER UP CONDITION TO SEE IF THE REPORTED COMPLAINT COULD BE DUPLICATED. DURING THE HALF HOUR, THE DISPLAY HEAD/IABP NEVER SWITCHED STATES (BETWEEN MONITOR AND TRANSDUCER). THE IABP WAS THEN LEFT TO RUN FOR OVER 2 HOURS AND NO ISSUES WERE NOTED (SWITCH BETWEEN MONITOR TO TRANSDUCER, AND NO STATIC TRANSDUCER PRESSURE WHILE IN AUTO MODE). 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. SEE OTHER REMARKS SECTION. OTHER REMARKS: CONCLUSION: THE REPORTED COMPLAINT OF "STATIC TRANSDUCER PRESSURE AND SWITCH BETWEEN MONITOR & TRANSDUCER" WAS CONFIRMED BY THE FIELD SERVICE ENGINEER; HOWEVER, THE REPORTED PROBLEM COULD NOT BE REPRODUCED AT TELEFLEX (B)(4) DURING THE FUNCTIONAL TEST. THE I/O BOARD PASSED FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PATIENT COMING OFF BY-PASS LOST AP SIGNAL. FINDINGS/ACTION TAKEN: FOUND ANY TIME A STATIC AP PRESSURE ON TRANSDUCER LINE - WOULD SWITCH BETWEEN MONITOR & TRANSDUCER - IN AUTO REPLACED 1/0 PCB - NO LONGER SWITCHES BETWEEN TRANSDUCER & MONITOR WITH NO OR STATIC TRANSDUCER PRESSURE - IN AUTO PERFORMED FUNCTIONAL CHECKS AND PASSED ALL. ON 07/15/2016- ADDITIONAL INFORMATION RECEIVED: AS A RESULT OF THE AP SIGNAL LOST THE USER SWAPPED THE PUMP OFF THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD (B)(4). SYMPTOM: PATIENT COMING OFF BY-PASS LOST AP SIGNAL. FINDINGS/ACTION TAKEN: FOUND ANY TIME A STATIC AP PRESSURE ON TRANSDUCER LINE - WOULD SWITCH BETWEEN MONITOR & TRANSDUCER - IN AUTO REPLACED 1/0 PCB - NO LONGER SWITCHES BETWEEN TRANSDUCER & MONITOR WITH NO OR STATIC TRANSDUCER PRESSURE - IN AUTO PERFORMED FUNCTIONAL CHECKS AND PASSED ALL. ON 07/15/2016- ADDITIONAL INFORMATION RECEIVED: AS A RESULT OF THE AP SIGNAL LOST THE USER SWAPPED THE PUMP OFF THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459890 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001068978

    Patients

    Seq Age Sex Outcome Treatment
    1