BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN FLASH

    MDR report key: 1386414 · Received May 14, 2009

    Report

    Report Number
    1423500-2009-00226
    Event Type
    Injury
    Date Received
    May 14, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 22, 2009
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT OF PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL (UNK) PERITONEAL THERAPY (PD) AND ASKED ABOUT THE ERROR OF CLEAN FLASH (UV ASSIST DEVICE). IT WAS REPORTED THAT THE SENSOR'S FUNCTION OF THE CLEAN FLASH SEEMED TO BE GETTING WEAKER. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF PERITONITIS. IN 2009, THE PATIENT STARTED DIANEAL N PD-2 1.5% AND DIANEAL N PD-2 2.5% FOR AMBULATORY PERITONEAL DIALYSIS (APD) THERAPY. IN THE SAME MONTH, THE PATIENT DEVELOPED HERPES ZOSTER. NO TREATMENT WAS ADMINISTERED AND THE PATIENT RECOVERED. A WEEK AFTER THE ORIGINAL DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF DEHYDRATION. ON ADMISSION, THE PERITONEAL EFFLUENT WAS CULTURED. PERITONEAL LAVAGE WAS PERFORMED FIVE TIMES A DAY FOR SIX DAYS FROM THE SAME DAY. CEFAZOLIN SODIUM AND AMIKACIN SULFATE (DOSE UNK) WERE ADMINISTERED INTRAPERITONEAL (IP) STARTING THAT DAY. THREE DAYS LATER, THE PATIENT RECOVERED FROM THE DEHYDRATION. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THERE WERE NO KNOWN EXIT SITE OR TUNNEL INFECTIONS, NO BREAKS IN ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN FLASH 78KDJ KDJ MED-TECH INC. 12624

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DINEAL 2.5%| DINEAL 1.5%