BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IABP CATHETER KIT

    MDR report key: 5923620 · Received September 1, 2016

    Report

    Report Number
    2032677-2016-00009
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 1, 2016
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K082746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A CUSTOMER EXPERIENCED GAS LEAK ALARMS ON AN ARROW AUTOCAT 2 WAVE CONSOLE APPROXIMATELY ONE DAY POST OPEN-HEART SURGERY. BASED ON THE REPORT, THE IAB WAS FUNCTIONING PROPERLY WHILE THE PATIENT WAS IN THE OPERATING THEATER AND THE GAS ALARMS TRIGGERED AFTER THE PATIENT HAD BEEN TRANSFERRED TO THE ICU. THE HELIUM GAS PRESSURE BEGAN DROPPING, FOLLOWED BY A FAILURE TO INFLATE THE BALLOON. THE ON-SITE NURSE IDENTIFIED A LEAK AT THE Y-CONNECTOR OF THE IAB CATHETER. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574735 ULTRA IABP CATHETER KIT INTRA AORTIC BALLOON CATHETER DSP INSIGHTRA MEDICAL, INC. IMUF7-35 12071502

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention