BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CPB

    MDR report key: 3843235 · Received March 14, 2014

    Report

    Report Number
    2248146-2014-00025
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 18, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED, THEREFORE NO EVALUATION CAN BE PERFORMED. IF THE DEVICE BECOMES AVAILABLE OR ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. RELATED TO MFR REPORT #'S: 2248146-2014-00022, 00025; 00026; 00027; 00028; 00029; 00030; 00031; 00032; 00033; 00034; 00035; 00036; 00037; 00038; 00039; 00040; 00042; AND 00043.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 20 BO-TOP 42802 PACKS AS A SUBSTITUTION TO THE REGULAR PACKS USED AT THIS FACILITY. IT WAS REPORTED THAT THE DESIGN OF THE PACK IS SUCH THAT THE PRE-BYPASS FILTER IS IN THE MIDDLE OF THE ARTERIAL-VENOUS LOOP, SEPARATING THE 3/8" ARTERIAL TUBING FROM THE 1/2" VENOUS TUBING. DESPITE CIRCULATING THE FLUID THROUGH THE CIRCUIT IN THE CUSTOMARY FASHION, SMALL BUBBLES PERSISTED ON THE VENOUS SIDE OF THE LOOP. PERFUSION STAFF TRIED A NUMBER OF DIFFERENT METHODS TO REMEDIATE, HOWEVER THE FINAL SOLUTION BECAME RE-ATTACHING THE ARTERIAL-VENOUS LOOP AFTER REMOVING THE PRE-BYPASS FILTER AND RE-CIRCULATING THE PRIME FLUID THROUGH THE CIRCUIT. IT WAS REPORTED THAT THE MALFUNCTION OCCURRED PRIOR TO USE ON A PT AND THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153479 ADULT CPB CARDIOPULMONARY DEVICE DWF DATASCOPE CORP BO-TOP 42802 15082-08

    Patients

    Seq Age Sex Outcome Treatment
    1