BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLS CUSTOM PACK BO-TOP 20705

    MDR report key: 7310903 · Received March 2, 2018

    Report

    Report Number
    2248146-2018-00135
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 1, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXTRA CORPOREAL LIFE SUPPORT (ECLS) PROCESS, THE BLADDER COMPONENT IN THE CUSTOM ECLS PACK BO-TOP 20705 CIRCUIT LEAKED. THE BLADDER COMPONENT WAS REMOVED FROM THE CIRCUIT AND WAS RETURNED DIRECTLY TO THE ORIGINAL EQUIPMENT MANUFACTURER BY THE FACILITY. THE FACILITY REPORTED THERE WAS NO INJURY TO THE PATIENT AND THEY WOULD NOT RELEASE ANY ADDITIONAL PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154581 ECLS CUSTOM PACK BO-TOP 20705 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000061302

    Patients

    Seq Age Sex Outcome Treatment
    1