BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961424 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00622
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF CLOUDY EFFLUENT OF MILD SEVERITY IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, LOT NUMBER 10D12G42, AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IN (B)(6) 2010, THE PATIENT EXPERIENCED SEVERAL EPISODES OF CLOUDY EFFLUENT AFTER THE EXTRANEAL DWELL. THE PATIENT WAS ASYMPTOMATIC AND WAS NOT TREATED WITH ANTIBIOTICS. ON (B)(6) 2010, THE EFFLUENT AFTER EXTRANEAL WAS CLEAR AND THE EVENT RESOLVED. EXTRANEAL VIAFLEX AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES WERE ONGOING. THE REPORTER BELIEVED THE CLOUDY EFFLUENT WAS RELATED TO EXTRANEAL VIAFLEX THERAPY, BUT NOT RELATED TO PHYSIONEAL 35 UNKNOWN BAG THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other ROCALTROL ("0,25" - NO UNITS SPECIFIED) PER DAY,| ARTEDIL (MANIDIPINE HYDROCHLORIDE) ("1",NO UNITS| SPECIFIED) AT NIGHT,| FUROSEMIDE ("2",NO UNITS SPECIFIED, 3 TIMES A DAY,| PARAPRES ("1", NO UNITS SPECIFIED) IN MORNING,| EXTRANEAL VIAFLEX AND PHYSIONEAL 35,| DOXAZOSINA (DOXAZOSIN) 4 MG, EVERY 12 HOURS,