BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 6294564 · Received February 1, 2017

    Report

    Report Number
    2248146-2017-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    January 6, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF PRODUCTS IN STOCK FROM THIS LOT HAS CONFIRMED THE REPORTED EVENT OF THE KITS BEING BUILT INCORRECTLY. REFERENCE: FIELD CORRECTION 2248146-02/16/2017-001C. (B)(4). MFR REPORT # 2248146-2017-00008.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 09:00 AM (GMT-5:00) ADDED BY (B)(6) (B)(4): 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 WILL CONTINUE IN OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR IT'S RETURN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75220 CUSTOM TUBING PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000033848

    Patients

    Seq Age Sex Outcome Treatment
    1