BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SEPARATOR APHERESIS KIT W/RESTRICTOR TUB

    MDR report key: 889355 · Received August 3, 2007

    Report

    Report Number
    2648979-2007-00003
    Event Type
    Malfunction
    Date Received
    August 3, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 5, 2007
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    Removal / Correction Number
    2007-0035-TT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE RETURNED BY THE THE FOREIGN CUSTOMER WAS VERIFIED VIA VISUAL INSPECTION TO HAVE THE AC AND SALINE TUBINGS SWITCHED. THE MANUFACTURING EVALUATORS DOCUMENTED THIS AS THE RED SPIKE ON THE SALINE LINE AND THE WHITE SPIKE ON THE AC LINE, WHICH IS THE SAME MISASSEMBLY. THE HEALTH HAZARD ASSOCIATED WITH THE SWITCHED AC AND SALINE TUBING IS POTENTIAL FOR EXCESSIVE AC INFUSION. THE PROBABLE CAUSE OF THIS DEFECT IS MANUFACTURING ERROR. BATCH RECORD REVIEW DID NOT IDENTIFY ANY ISSUES DURING PRODUCTION.

    Description of Event or Problem · 1

    ON 06/21/2007, A DONOR CENTER IN A FOREIGN COUNTRY NOTED DURING THE PRIME PROCESS STEP, REQUIRED PRIOR TO STARTING AN APHERESIS PROCEDURE, THAT THE ANTICOAGULANT TUBING AND SALINE TUBING OF THE APHERESIS KIT WERE MISASSEMBLED. THEY DID NOT REPORT THIS UNTIL 07/04/2007 WHEN A BAXTER ENGINEER COME TO CHECK THE INSTRUMENT. THE ENGINEER CONFIRMED THEY HAD RECEIVED THE NOTIFICATION. THE BAXTER ENGINEER REPORTED THIS EVENT TO FENWAL QA, INDICATING IT IS THE SAME MISASSEMBLY DESCRIBED IN THE FCA. THIS MISSASSEMBLY HAS THE POTENTIAL TO RESULT IN EXCESSIVE INFUSION OF ANTICOAGULANT. THERE WAS NO DONOR INVOLVEMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL SEPARATOR APHERESIS KIT W/RESTRICTOR TUB CS3000 APHERESIS KIT GKT FENWAL, INC. NA N06C23026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR