BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE ITALIAN

    MDR report key: 4755967 · Received May 6, 2015

    Report

    Report Number
    1219856-2015-00096
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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 FOUND THE BRASS FITTING TIP OF THE INLET PORT WAS BROKEN. TO BE ABLE TO PERFORM A FURTHER INVESTIGATION, THE BROKEN BRASS FITTING WAS REPLACED WITH A KNOWN GOOD ONE. THE PCS ASSEMBLY IN QUESTION WAS THEN INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND THE FUNCTIONAL TEST WAS PERFORMED. THE PCS ASSEMBLY PASSED FUNCTIONAL TESTING. THE PUMP WAS LEFT TO RUN FOR OVER 2 HOURS AND NO ALARMS OR ERRORS WERE OCCURRED. NOTICE: WITHOUT A HELIUM TUBE CONNECTED TO THE INLET PORT, THE PUMP WILL ALARM "LOW HELIUM TANK PRESSURE" MESSAGE. ALSO IF THE STANDBY OR ON BUTTON HAS BEEN PRESSED BEFORE THE "LOW HELIUM TANK PRESSURE" MESSAGE OCCURS, THE PUMP WILL ALARM "PURGE FAILURE." THE PCS ASSEMBLY IN QUESTION WAS THEN INSTALLED ONTO THE LEAK TESTER AND PASSED LEAK TESTING. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITY WAS FOUND. 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 "ALARM, HELIUM LOSS" IS CONFIRMED BY TELEFLEX (B)(4). THE REPORTED PROBLEM COULD NOT BE REPRODUCED AT TELEFLEX (B)(4) DURING THE FUNCTIONAL TEST. THE CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED. THE BRASS FITTING TIP OF THE INLET PORT WAS NOTED TO BE BROKEN DURING VISUAL INSPECTION. THIS DAMAGE IS UNRELATED TO THE REPORTED COMPLAINT. THE CAUSE OF THE BROKEN BRASS FITTING IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VIA AN (EQR) EQUIPMENT QUALITY REPORT: HELIUM LOSS ERROR DURING THERAPY, AND MEDICAL STAFF SWITCHED FOR ANOTHER AND AVAILABLE (IABP) INTRA-AORTIC BALLOON PUMP. NO FURTHER COMPLICATIONS ON THERAPY. THE IABP NEEDS SERVICE. ACTIONS: PCS REPLACED. OP = ON PATIENT. (B)(6) 2015 - ADDITIONAL INFORMATION RECEIVED: THE IAB USED FOR THE PATIENT WAS FOUND TO BE FAULTY. THE PUMP ALARMED HELIUM ALARM CLASS 1. AN IAB REPORT WAS NOT SUBMITTED TO TELEFLEX. FIELD SERVICE REP. THE PCS WAS NOT FUNCTIONING APPROPRIATELY AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296584 AUTOCAT2 WAVE ITALIAN IABP AUTOCAT 2 WAVE PUMP CONSOLE DSP ARROW INTERNATIONAL INC. 0000757009

    Patients

    Seq Age Sex Outcome Treatment
    1