BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-TOP 40700 PEDIATRIC SPECIALTY PACK

    MDR report key: 6678833 · Received June 29, 2017

    Report

    Report Number
    2248146-2017-00067
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 14, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED. A PICTURE WAS PROVIDED AND THEREFORE THE EVALUATION IS BASED ON THE PHOTOGRAPH ONLY. AN EVALUATION WAS PERFORMED WHICH CONFIRMED THE KINK IN THE LINE PRE OXYGENATOR. WE WERE UNABLE TO DETERMINE THE ROOT CAUSE. THE KINKS REPORTED TO BE POST OXYGENATOR AND ABOVE THE BLADDER WERE UNABLE TO BE CONFIRMED SINCE THE PRODUCT WAS NOT RETURNED AND THERE WERE NO PICTURES PROVIDED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. (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

    IT WAS REPORTED BY THE CUSTOMER DURING SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE TUBING WAS BENT PRE-OXYGENATOR, POST-OXYGENATOR, AND JUST ABOVE THE BLADDER. SUPPORT WAS PLACED AROUND THE BENT AREAS. THERE WAS NO INJURY OR HARM TO THE PATIENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER DURING SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE TUBING WAS BENT PRE-OXYGENATOR, POST-OXYGENATOR, AND JUST ABOVE THE BLADDER. SUPPORT WAS PLACED AROUND THE BENT AREAS. THERE WAS NO INJURY OR HARM TO THE PATIENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER DURING SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE TUBING WAS BENT PRE-OXYGENATOR, POST-OXYGENATOR, AND JUST ABOVE THE BLADDER. SUPPORT WAS PLACED AROUND THE BENT AREAS. THERE WAS NO INJURY OR HARM TO THE PATIENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459525 BEQ-TOP 40700 PEDIATRIC SPECIALTY PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000030748

    Patients

    Seq Age Sex Outcome Treatment
    1