BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-TOP 701056688 ECC 1/4" QUADROXID W/RF

    MDR report key: 6300366 · Received February 3, 2017

    Report

    Report Number
    2248146-2017-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 28, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED - 'OUTCOME ATTRIBUTED TO AE' SHOULD BE BLANK ON INITIAL EMDR AS THERE WAS NO ADVERSE EVENT. COMPLAINT RECORD # (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WE'RE UNABLE TO COMPLETE AN EVALUATION ON THE AFFECTED PRODUCT. WHEN IT'S PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH ADDITIONAL FINDINGS. WE CONTINUE IN OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR ITS RETURN. (B)(4).

    Description of Event or Problem · 1

    "BACK-UP" ECLS CIRCUIT SET-UP AND PRIMED. SLOW CRYSTALLOID LEAK WAS NOTED AT THE SWIVEL ATTACHMENT ON THE A-V BRIDGE DURING PRIMING OF CIRCUIT. THE SWIVEL ATTACHMENT WAS REMOVED AND REPLACED WITH A STOPCOCK, LEAK RESOLVED. CIRCUIT WILL BE UTILIZED AS A BACK-UP ECLS CIRCUIT WHEN NEEDED. THIS IS PROTOCOL FOR FACILITY TO HAVE A BACK-UP CIRCUIT AVAILABLE AT ALL TIMES. THIS CIRCUIT WAS NOT USED ON A PATIENT. THE CIRCUIT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    "BACK-UP" ECLS CIRCUIT SET-UP AND PRIMED. SLOW CRYSTALLOID LEAK WAS NOTED AT THE SWIVEL ATTACHMENT ON THE A-V BRIDGE DURING PRIMING OF CIRCUIT. THE SWIVEL ATTACHMENT WAS REMOVED AND REPLACED WITH A STOPCOCK, LEAK RESOLVED. CIRCUIT WILL BE UTILIZED AS A BACK-UP ECLS CIRCUIT WHEN NEEDED. THIS IS PROTOCOL FOR FACILITY TO HAVE A BACK-UP CIRCUIT AVAILABLE AT ALL TIMES. THIS CIRCUIT WAS NOT USED ON A PATIENT. THE CIRCUIT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82215 BEQ-TOP 701056688 ECC 1/4" QUADROXID W/RF TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000032110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention