BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK BO-T 25102

    MDR report key: 6449327 · Received March 31, 2017

    Report

    Report Number
    2248146-2017-00023
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. UPON INVESTIGATION OF THE PRODUCT THE TUBING WAS SECTIONED AND TUBING WALLS MEASURED. THE WALL THICKNESS IS 0.935 +/- 0.003 PER SPECIFICATION. TUBING FROM LOT 3000034884 MEASURED 0.0935 AND 0.0910 IN 2 PLACES. IT WAS DETERMINED THE CORRECT TUBING MATERIAL WAS USED. THE TUBING WAS OF CORRECT SIZE AND DUROMETER. NO ROOT CAUSE COULD BE DETERMINED AS THE MATERIAL MET THE REQUIRED SPECIFICATIONS. THE COMPLAINT CANNOT BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    INITIAL MDR SECTION PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. EVENT OR PROBLEM' CHANGED FROM : THERE WAS NO PATIENT INJURY IN THIS CASE. TO: THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE. COMPLAINT RECORD # (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PERFUSIONIST QUESTIONED THE CORRECT THICKNESS/STIFFNESS OF THE CUSTOM TUBING AND MENTIONED IT FELT MUCH THINNER THAN IN THE PAST. THERE WAS NO PATIENT INJURY IN THIS CASE.

    Description of Event or Problem · 1

    THE PERFUSIONIST QUESTIONED THE CORRECT THICKNESS/STIFFNESS OF THE CUSTOM TUBING AND MENTIONED IT FELT MUCH THINNER THAN IN THE PAST. THERE WAS NO PATIENT INVOLEMENT IN THIS CASE.

    Description of Event or Problem · 1

    THE PERFUSIONIST QUESTIONED THE CORRECT THICKNESS/STIFFNESS OF THE CUSTOM TUBING AND MENTIONED IT FELT MUCH THINNER THAN IN THE PAST. THERE WAS NO PATIENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232110 CUSTOM PACK BO-T 25102 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000034884

    Patients

    Seq Age Sex Outcome Treatment
    1