BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 14437871 · Received May 19, 2022

    Report

    Report Number
    3010532612-2022-00180
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 21, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF FAILED BATTERY LOAD TEST IS CONFIRMED. THE RETURNED BATTERY FAILED THE BATTERY LOAD TEST. DURING THE COMPLAINT INVESTIGATION, THE PUMP SHUT OFF AFTER 21 MINUTES WHEN OPERATING ON BATTERY POWER AFTER A FULL CHARGE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT A POTENTIAL CAUSE OF THE SHORT BATTERY LIFE IS A RESULT OF MAINTAINING OF THE BATTERY. IABP USERS AND SERVICERS MUST FOLLOW THE OPERATING INSTRUCTIONS MANUAL FOR RECOMMENDATIONS ON USAGE, CHARGING, MAINTENANCE AND STORAGE OF THE BATTERIES. IF BATTERY MAINTENANCE IS NOT PERFORMED PER THE IABP OPERATING INSTRUCTIONS MANUAL, THE BATTERY MAY NOT PROVIDE THE EXPECTED MINIMUM RUN TIME OF OPERATING POWER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE PUMP FAILED THE BATTERY LOAD TEST.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE PUMP FAILED THE BATTERY LOAD TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260732 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.| NI.