BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5776377 · Received July 7, 2016

    Report

    Report Number
    1219856-2016-00150
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 9, 2016
    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

    QN#(B)(4). THE PCS ASSEMBLY (P/N 96-3006-001, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITY WAS FOUND. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED PASSED THE FUNCTIONAL TEST. THE PURGE CYCLE WAS PERFORMED MULTIPLE TIMES WITH NO ALARMS OR ERRORS. THE PUMP WAS THEN LEFT TO RUN FOR OVER SIX HOURS WITHOUT ANY ISSUES. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE MDT-50 LEAK TESTER AND PASSED LEAK TESTING. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITY WAS FOUND. PER SERVICE HISTORY REPORTED, THE PCS ASSEMBLY WAS REPLACED ON NOVEMBER 22, 2005. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IABP SERIAL/ LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. OTHER REMARKS: CONCLUSION: THE REPORTED PROBLEM OF PURGE FAILURE ALARM IS NOT CONFIRMED. THE REPORTED PROBLEM COULD NOT BE REPRODUCED DURING THE FUNCTIONAL TEST. THE PCS ASSEMBLY 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 - L610990. PUMP HAD PURGE FAILURE ALARM WHEN FIRST PUT ON PATIENT. PUMP WAS SWITCHED OUT QUICKLY WITHOUT DELAY OR IMPACT TO PATIENT. FINDINGS/ACTIONS TAKEN: CONFIRMED- PCS ASSEMBLY REPLACED. PARTS SENT TO AND REPLACED BY HOSPITAL BIOMED. DEFECTIVE PCS ASSY. TO BE RETURNED ON (B)(4). FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT - (B)(4). PUMP HAD PURGE FAILURE ALARM WHEN FIRST PUT ON PATIENT. PUMP WAS SWITCHED OUT QUICKLY WITHOUT DELAY OR IMPACT TO PATIENT.FINDINGS/ACTIONS TAKEN: CONFIRMED- PCS ASSEMBLY REPLACED. PARTS SENT TO AND REPLACED BY HOSPITAL BIOMED. DEFECTIVE PCS ASSY. TO BE RETURNED ON (B)(4). FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430316 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001055365

    Patients

    Seq Age Sex Outcome Treatment
    1