BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1176226 · Received September 25, 2008

    Report

    Report Number
    1423500-2008-00822
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    April 8, 2007
    Report Date
    April 27, 2007
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO BAXTER TECHNICAL SERVICES. THE REPORT WAS REQUESTED BY THE LOCAL COMPLAINT OWNER BUT WAS NOT TRANSLATED IN ENGLISH. THE RESULTS OF THE EVAL WILL BE PROVIDED IN A FOLLOW-UP REPORT UPON RECEIPT OF THE ENGLISH TRANSLATION.

    Description of Event or Problem · 1

    IN 2007, BAXTER RECEIVED A CASE REPORT FROM FRANCE THAT REFERS TO A FEMALE PT WHO UNDERWENT A PERITONEAL DIALYSIS USING A UV-FLASH MACHINE, AND A UV TRANSFER SET (LOT H05J10095) ON NINE DAYS EARLIER. THE SET WAS CONNECTED TO THIS PT SINCE 2006. IT IS REPORTED THAT THE MACHINE HAD ALARMED, DIODES LIGHTS 3 AND 5 SWITCHED ON. WHEN THE DOOR WAS OPENED, THE SPIKE WAS ABOVE THE CHIMNEY OF THE NEW BAG. CONSEQUENTLY, THE TRANSFER SET WAS CHANGED ALTHOUGH THERE WAS NO VISIBLE DAMAGE ON IT. ACCORDING TO THE REPORTER, THE PT EXPERIENCED A PERITONEAL INFECTION AS A CONSEQUENCE. SHE RECEIVED FORTUM (CEFTAZIDIME) 1 G DAILY FOR THREE DAYS, VANCOMYCIN 1G ON A WEEK PRIOR TO ORIGINAL DATE. BAGS AND LINE WERE DISCARDED. THE MACHINE WAS RETURNED TO BAXTER TECHNICAL SERVICES. THIS REPORT IS FOR THE RTC4516 DEVICE MANUFACTURED IN OTHER COUNTRY, DISTRIBUTED BY BAXTER IN EUROPE, BUT HAS SAME OR SIMILAR DEVICES IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE 78KDJ KDJ MED-TECH INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R