BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMATRON III

    MDR report key: 414545 · Received August 29, 2002

    Report

    Report Number
    1420141-2002-00051
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    July 13, 2002
    Report Date
    July 31, 2002
    Manufacturer
    CONROY MEDICAL AB
    Product Code
    KSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A HEMATRON III WAS THE SOURCE OF ENTEROBACTERIA CONTAMINATION IN PLATELET UNITS AND 2 SAMPLE SEGMENTS. THE PLATELETS HAD BEEN INFUSED IN AN UNK NUMBER OF PTS WHO WERE SUBSEQUENTLY TREATED FOR SEPTIC SHOCK. THE CENTER TESTED FOR THE BACTERIA IN ALL THE LAB EQUIPMENT AND FOUND THE SAME ORGANISM THAT INFECTED THE PTS ON THE HEMATRON III. IT WAS FOUND ON NO OTHER LAB EQUIPMENT. THE REPORTING HOSPITAL MADE ASSUMPTION THAT THE HEMATRON III WAS THE SOURCE OF THE CONTAMINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMATRON III SEALER KSD CONROY MEDICAL AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other