BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX

    MDR report key: 6901855 · Received September 28, 2017

    Report

    Report Number
    2248146-2017-00420
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 7, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS SENT TO THE SUPPLIER FOR EVALUATION AND THE REPORTED LEAK COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A VERY SMALL AND SLOW LEAK OUT OF THE DIALYSIS LOCK AND LUER PORT. IT WAS NOTED THAT THERE MAY HAVE BEEN A LOOSE CAP. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A VERY SMALL AND SLOW LEAK OUT OF THE DIALYSIS LOCK AND LUER PORT. IT WAS NOTED THAT THERE MAY HAVE BEEN A LOOSE CAP. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A VERY SMALL AND SLOW LEAK OUT OF THE DIALYSIS LOCK AND LUER PORT. IT WAS NOTED THAT THERE MAY HAVE BEEN A LOOSE CAP. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680436 CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000047037

    Patients

    Seq Age Sex Outcome Treatment
    1