BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5623782 · Received May 2, 2016

    Report

    Report Number
    1219856-2016-00103
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 15, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 NO ABNORMALITIES WERE NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED FAILED THE FUNCTIONAL TEST. THE PUMP ALARMED "HELIUM LOSS 2" APPROXIMATELY TWO MINUTES AFTER INITIATED PUMPING. THE PCS ASSEMBLY WAS THEN REMOVED FROM THE PUMP. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE LEAK TESTER AND FAILED LEAK TESTING. A LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. RUST AND DRIED CONDENSATION WAS FOUND INSIDE THE DRAIN VALVE AND MANIFOLD BLOCK WHERE THE DRAIN VALVE CONNECTED TO. A PIECE OF A HARD OBJECT WAS ALSO NOTED INSIDE THE DRAIN VALVE. NOTICE: THIS IS AN ORIGINAL PCS ASSEMBLY, AND THIS IS A 2004 IABP. 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 "HELIUM LOSS ALARM" IS CONFIRMED. THE REPORTED PROBLEM WAS REPLICATED DURING THE FUNCTIONAL TEST. THE PUMP ALARMED "HELIUM LOSS 2" APPROXIMATELY TWO MINUTES AFTER INITIATING PUMPING. A LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT, AND THAT CAUSED THE HELIUM LOSS ALARM. RUST, DRIED CONDENSATION, AND A PIECE OF A HARD OBJECT WERE FOUND INSIDE THE DRAIN VALVE, AND THAT CAUSED THE DRAIN VALVE MALFUNCTION. THE ROOT CAUSE OF HOW THE HARD OBJECT GOT INSIDE THE DRAIN VALVE IS UNDETERMINED. ENGINEERING HAS BEEN NOTIFIED OF THE EVENT, AND THIS ISSUE WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PUMP HAS HELIUM LOSS #2 ALARMS. FINDINGS/ACTION TAKEN: REPLACED PNEUMATIC CONTROL ASSEMBLY. ADDITIONAL INFORMATION STATED THAT THIS PUMP WAS ON A PATIENT WHEN THEY EXPERIENCED HELIUM LOSS #2 ALARMS. IT WAS SWITCHED OUT IMMEDIATELY WITH NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PUMP HAS HELIUM LOSS #2 ALARMS. FINDINGS/ACTION TAKEN: REPLACED PNEUMATIC CONTROL ASSEMBLY. ADDITIONAL INFORMATION STATED THAT THIS PUMP WAS ON A PATIENT WHEN THEY EXPERIENCED HELIUM LOSS #2 ALARMS. IT WAS SWITCHED OUT IMMEDIATELY WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278529 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001020191

    Patients

    Seq Age Sex Outcome Treatment
    1