BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1176227 · Received September 25, 2008

    Report

    Report Number
    1423500-2008-00823
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    March 10, 2007
    Report Date
    April 17, 2007
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    Adverse Event
    Yes
    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 BECAME AWARE OF A REPORT FROM FRANCE THAT REFERS TO A FEMALE PT WHO UNDERWENT A PERITONEAL DIALYSIS (PD) USING A UV-FLASH MACHINE, AND A UV TRANSFER SET (LOT H05J10095). THE SET WAS CONNECTED TO THIS PT SINCE 2006. ON A MONTH EARLIER, THE PT WAS HOSPITALIZED FOR PERITONITIS (CLOUDY DIALYSATE) WHILE UNDER EXTRANEAL TREATMENT. SHE HAD NO ASSOCIATED CLINICAL SYMPTOMS OR LOSS IN ULTRAFILTRATION (UF). ON THE SAME DAY, SHE RECEIVED VANCOMYCIN, 1G, INTRAPERITONEAL (IP) AND FORTUM (CEFTAZIDIME), 1G, IP, FORTUM, 1G WAS FURTHER CONTINUED FOR AN UNREPORTED PERIOD. THE DIALYSATE CULTURE WAS NEGATIVE. (IT COULD NOT BE FOUND OUT WHICH EXTRANEAL BATCH WAS PRECISELY USED, HOWEVER, THE LAST BATCHES DELIVERED PRIOR TO THE EVENT WERE DEVICE FOR EXTRANEAL AND DEVICE FOR NUTRINEAL). PD TREATMENT WAS CONTINUED UNCHANGED. ON THAT MONTH, THE PT WAS CONSIDERED AS RECOVERED AND WAS DISCHARGED FROM HOSPITAL. THIS REPORT IS AGAINST THE DEVICE WHICH WAS MANUFACTURED IN OTHER COUNTRY, DISTRIBUTED IN OTHER COUNTRY, BUT IS THE SAME OR SIMILAR TO UV FLASH HARDWARE 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 EXTRANEAL AND DEVICE FOR NUTRINEAL.| DELIVERED PRIOR TO THE EVENT WERE DEVICE FOR| WAS PRECISELY USED| IT COULD NOT BE FOUND OUT WHICH EXTRANEAL BATCH