BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 14251870 · Received April 29, 2022

    Report

    Report Number
    3010532612-2022-00150
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    (B)(4). NO IABP PART OR RECORDER STRIP WAS RETURNED TO TELEFLEX CHELMSFORD FOR INVESTIGATION. THE REPORTED COMPLAINT OF BATTERY REPLACED IS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. THE SPECIFIC SERIAL NUMBER WAS NOT REPORTED, BUT A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR ALL THE LOT NUMBERS/SERIAL NUMBERS OF AUTOCAT2 SERIES (AC2) AT THIS ACCOUNT WITH ONE RELEVANT FINDING. A NONCONFORMANCE IS RELEVANT AND CORRESPONDS TO A SIMILAR ISSUE AS THE COMPLAINT. ALL NONCONFORMING DEVICES WERE SCRAPPED. ALL RELEASED PRODUCT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE PUMP HAD BATTERY ISSUES. LIMITED INFORMATION WAS RECEIVED FOR THIS COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE PUMP HAD BATTERY ISSUES. LIMITED INFORMATION WAS RECEIVED FOR THIS COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119227 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown