BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG¿

    MDR report key: 16067501 · Received December 29, 2022

    Report

    Report Number
    16067501
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    September 3, 2022
    Report Date
    December 13, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORD TO PUMP WAS PULLED OUT OF CONSOLE INSTEAD OF SCREEN CORD. PUMP CORD PLUGGED BACK IN. CONSOLE POWERED OFF AND REBOOTED. AFTER REBOOT, FLOWS INCREASED TO ORIGINAL SETTINGS, BUT NO FLOW LISTED ON SCREEN AND S3 ALARM WAS SHOWING. AT THIS POINT AN EMERGENT CONSOLE CHANGE WAS PERFORMED AT THE BESIDE WITH 2 NPS. PT TOLERATED OCCURRENCE AND WAS NOT HARMED FROM THE EVENT.

    Description of Event or Problem · 0

    CORD TO PUMP WAS PULLED OUT OF CONSOLE INSTEAD OF SCREEN CORD. PUMP CORD PLUGGED BACK IN. CONSOLE POWERED OFF AND REBOOTED. AFTER REBOOT, FLOWS INCREASED TO ORIGINAL SETTINGS, BUT NO FLOW LISTED ON SCREEN AND S3 ALARM WAS SHOWING. AT THIS POINT AN EMERGENT CONSOLE CHANGE WAS PERFORMED AT THE BESIDE WITH 2 NPS. PT TOLERATED OCCURRENCE AND WAS NOT HARMED FROM THE EVENT.

    Description of Event or Problem · 0

    CORD TO PUMP WAS PULLED OUT OF CONSOLE INSTEAD OF SCREEN CORD. PUMP CORD PLUGGED BACK IN. CONSOLE POWERED OFF AND REBOOTED. AFTER REBOOT, FLOWS INCREASED TO ORIGINAL SETTINGS, BUT NO FLOW LISTED ON SCREEN AND S3 ALARM WAS SHOWING. AT THIS POINT AN EMERGENT CONSOLE CHANGE WAS PERFORMED AT THE BESIDE WITH 2 NPS. PT TOLERATED OCCURRENCE AND WAS NOT HARMED FROM THE EVENT.

    Description of Event or Problem · 0

    CORD TO PUMP WAS PULLED OUT OF CONSOLE INSTEAD OF SCREEN CORD. PUMP CORD PLUGGED BACK IN. CONSOLE POWERED OFF AND REBOOTED. AFTER REBOOT, FLOWS INCREASED TO ORIGINAL SETTINGS, BUT NO FLOW LISTED ON SCREEN AND S3 ALARM WAS SHOWING. AT THIS POINT AN EMERGENT CONSOLE CHANGE WAS PERFORMED AT THE BESIDE WITH 2 NPS. PATIENT (PT) TOLERATED OCCURRENCE AND WAS NOT HARMED FROM THE EVENT.

    Description of Event or Problem · 0

    CORD TO PUMP WAS PULLED OUT OF CONSOLE INSTEAD OF SCREEN CORD. PUMP CORD PLUGGED BACK IN. CONSOLE POWERED OFF AND REBOOTED. AFTER REBOOT, FLOWS INCREASED TO ORIGINAL SETTINGS, BUT NO FLOW LISTED ON SCREEN AND S3 ALARM WAS SHOWING. AT THIS POINT AN EMERGENT CONSOLE CHANGE WAS PERFORMED AT THE BESIDE WITH 2 NPS. PT TOLERATED OCCURRENCE AND WAS NOT HARMED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424556 CENTRIMAG¿ ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS DTZ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA Male