BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN FLASH

    MDR report key: 1373286 · Received April 28, 2009

    Report

    Report Number
    1423500-2009-00198
    Event Type
    Injury
    Date Received
    April 28, 2009
    Date of Event
    February 1, 2009
    Report Date
    April 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER TECHNICAL SERVICE CENTER RECEIVED THE DEVICE, AND SENT IT TO MED-TECH (MANUFACTURER) FOR EVALUATION, DUE TO THE PERITONITIS CASE. NO PROBLEM WAS FOUND BY VISUAL INSPECTION. PERFORMED UV FLASH TEST AND FUNCTIONAL TEST, AND THE DEVICE PASSED ALL TESTS. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IN 2009, BAXTER WAS INFORMED ABOUT A PATIENT WHO DEVELOPED BACTERIAL PERITONITIS WHILE ON A CLEAN FLASH DEVICE. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD-4 1.5% UV TWIN BAG 1500ML 3 TIMES/DAY. TWO DAYS LATER, FOLLOW UP CONTACT WAS MADE WITH THE PATIENT'S NURSE. THE NURSE STATED THE PATIENT HAD PERITONITIS ON THREE DAYS PRIOR TO ORIGINAL DATE, AND WAS TREATED WITH ANTIBIOTICS (SHE WAS NOT HOSPITALIZED). ON THE NEXT DAY, THE NURSE ASKED THE PATIENT ABOUT THE CAUSE OF THE PERITONITIS, THE PATIENT TOLD THAT HER CLEAN FLASH HAD AN ABNORMAL NOISE FROM TWO MONTHS EARLIER. THE NURSE INDICATED THE PATIENT WANTED TO EXCHANGE HER CLEAN FLASH. AS OF TWO DAYS AFTER THE ORIGINAL DATE, THE PATIENT WAS RECOVERING FROM THE EVENT AND PERITONEAL DIALYSIS (PD) THERAPIES WERE ONGOING. ANOTHER TWO DAYS LATER, A DOCTOR PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT HAD BACTERIAL PERITONITIS THREE DAYS PRIOR TO ORIGINAL DATE. THE PATIENT PRESENTED WITH CLOUDY EFFLUENT (NEUTROPHILS WAS 80% IN PERITONEAL EFFLUENT ERYTHROCYTES COUNT IN PERITONEAL EFFLUENT WAS 380/MM3), ABDOMINAL PAIN AND FEVER (38.5 DEGREE C). LEUCOCYTES COUNT IN HER BLOOD WAS 9000/MM3 AND C-REACTIVE PROTEIN WAS 2.0MG/DL. SHE WAS TREATED WITH AN ANTIBIOTIC INTRAPERITONEAL, 3TIMES/DAY, FOR SIX DAYS. ON THE SAME DATE, A GRAM STAIN WAS PERFORMED AND REVEALED GRAM-POSITIVE COCCUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1.5% UV TWINBAG 1500ML 3 TIMES PER DAY| DIANEAL N PD-4