BEUDAMED
    FDA Adverse Event Other Summary report: N

    UV-FLAAH AUTO

    MDR report key: 388531 · Received April 15, 2002

    Report

    Report Number
    1423500-2002-00458
    Event Type
    Other
    Date Received
    April 15, 2002
    Date of Event
    March 18, 2002
    Report Date
    March 18, 2002
    Manufacturer
    MED-TECH, INC
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER JAPAN COMPLAINT COORDINATOR REPORTED IN 2002, A PT CALLED TO THE PERITONEAL DIALYSIS CALL CENTER AND INFORMED AS FOLLOWS: THE PT WAS HOSPITALIZAED DUE TO PERITONITIS. THE TREATING PHYSICIAN SUSPECTED THE DECREASED ULTRA VIOLET (UV) POWER OF THE DEVICE AS ONE OF THE CAUSES OF PERITONITIS AND SUGGESTED TO SWAP THE DEVICE FOR A NEW ONE. COMPLAINT COORDINATOR FURTHER RELATES THAT USUALLY THE PT'S FAMILY MEMBER CHANGES DIALYSIS BAGS USING THE DEVICE, HOWEVER AT THIS TIME, THE PT DID IT. THE PT'S SKILL FOR USING THE DEVICE IS NOT GOOD ACCORDING TO THE BAXTER AFFILIATE'S REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLAAH AUTO UV-FLASH CAPD SYSTEM KDJ MED-TECH, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O