BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-TOP 36500 QUADROX OXYGENATOR

    MDR report key: 7029909 · Received November 14, 2017

    Report

    Report Number
    2248146-2017-00638
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 25, 2017
    Report Date
    February 27, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    SERIAL # WAS CHANGED FROM: UNKNOWN TO: N/A AS THIS DEVICE IS MANUFACTURED WITH A LOT # ONLY. THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS DISCARDED BY THE USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING THE CUSTOMER SAW LEAK FROM DIALYSIS LOCK AND LUER. THIS WAS FOUND BEFORE USE ON THE PATIENT AND THEREFORE NO RISK OF INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING THE CUSTOMER SAW LEAK FROM DIALYSIS LOCK AND LUER. THIS WAS FOUND BEFORE USE ON THE PATIENT AND THEREFORE NO RISK OF INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING THE CUSTOMER SAW LEAK FROM DIALYSIS LOCK AND LUER. THIS WAS FOUND BEFORE USE ON THE PATIENT AND THEREFORE NO RISK OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808504 BO-TOP 36500 QUADROX OXYGENATOR TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000052204

    Patients

    Seq Age Sex Outcome Treatment
    1