BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO BCT BLOOD COLLECTION SET

    MDR report key: 320217 · Received March 12, 2001

    Report

    Report Number
    MW4002954
    Event Type
    Malfunction
    Date Received
    March 12, 2001
    Report Date
    January 31, 2001
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MFG DEFECTS AND MATERIALS PROBLEMS OBSERVED IN VARIOUS LOTS OF GAMBRO BRAND APHERESIS BLOOD COLLECTION SETS FOR USE WITH COBE SPECTRA AUTOPHERESIS MACHINES. NO PT INJURIES RESULTED BUT PROCEDURES NEEDED TO BE LIMITED IN SCOPE TO 2 HRS OR LESS TO PREVENT LEAKAGE FROM DEFECTIVE TUBING SETS. PROBLEMS WITH THE PLASTIC RESIN USED IN THE SETS SEEMS TO HAVE BEEN LIMITED TO THOSE SETS IDENTIFIED AS HAVING BEEN PRODUCED SINCE A CHANGE IN FORMULATION IN SUMMER OF 2000. FORMULATION CORRECTED IN SETS PRODUCED 12/00. GAMBRO WILL REPLACE ALL SETS PRODUCED PRIOR TO DECEMBER. COMPLAINANT HAS PHOTOGRAPHS OF DEFECTIVE TUBING SETS AVAILABLE FOR COPYING IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10994 GAMBRO BCT BLOOD COLLECTION SET BLOOD COLLECTION SET LKN GAMBRO BCT, INC. NA VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO COBE SPECTRA APHERESIS MACHINE.