BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LA CHILDREN'S ECC PACK - BEQ-TOP 49103

    MDR report key: 6677804 · Received June 29, 2017

    Report

    Report Number
    2248146-2017-00059
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 9, 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

    THERE NO DECONTAMINATION OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED. THE PRODUCT WAS NOT RETURNED HOWEVER A PHOTOGRAPHIC EVALUATION WAS PERFORMED. PRODUCT WAS USED AND THEREFORE CAN NOT BE RETURNED. ACCORDING TO THE INVESTIGATION REPORT A COMPARISON OF THE PHOTO OF THE DEVICE, THE ASSEMBLY DRAWING, AND PACKAGING DRAWINGS WERE ANALYZED AND THERE WAS NO PROBLEMS FOUND. AFTER A REVIEW OF THE COMPLAINT, PRODUCTION PROCEDURES, AND SPECIFICATIONS IT WAS DETERMINED THE KIT WAS ASSEMBLED IN ACCORDANCE TO CUSTOMER SPECIFICATIONS. ADDITIONAL CHANGES WILL BE REQUIRED TO THE APPROVED CONFIGURATION AS REQUESTED BY THE CUSTOMER. 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. THE COMPLAINT COULD NOT BE CONFIRMED. (B)(4).

    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. WE CONTINUE OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR ITS RETURN. (B)(4).

    Description of Event or Problem · 1

    IT WAS THE REPORTED THAT DURING THE SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE WRAP WAS FOUND BACKWARDS AND ENDS UP TWISTING THE LINES UPON PRESENTATION OF THE LOOP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS THE REPORTED THAT DURING THE SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE WRAP WAS FOUND BACKWARDS AND ENDS UP TWISTING THE LINES UPON PRESENTATION OF THE LOOP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS THE REPORTED THAT DURING THE SET UP OF THE CUSTOM BUILT CARDIOPULMONARY TUBING PACK THE WRAP WAS FOUND BACKWARDS AND ENDS UP TWISTING THE LINES UPON PRESENTATION OF THE LOOP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460082 LA CHILDREN'S ECC PACK - BEQ-TOP 49103 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000046739

    Patients

    Seq Age Sex Outcome Treatment
    1