BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010

    MDR report key: 6547821 · Received May 5, 2017

    Report

    Report Number
    2248146-2017-00039
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 12, 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
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WAS HEMOCONCENTRATING AND NOTICED PINKISH COLORED FLUID COMING THROUGH THE EFFLUENT LINE. THE CUSTOMER SUSPECTED A FIBER LEAK. THE CUSTOMER REPLACED THE BEQ-TOP 40010 OPEN HEART PACK. THERE WAS NO PATIENT INJURY IN THIS CASE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS HEMOCONCENTRATING AND NOTICED PINKISH COLORED FLUID COMING THROUGH THE EFFLUENT LINE. THE CUSTOMER SUSPECTED A FIBER LEAK. THE CUSTOMER REPLACED THE BEQ-TOP 40010 OPEN HEART PACK. THERE WAS NO PATIENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328809 OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000033786

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR