BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1963049 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00732
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 28, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, D3 AND D4 ARE 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT 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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM POLAND OF STERILE PERITONITIS AND CYTOSIS (CODED AS LEUKOCYTOSIS) IN A PATIENT COINCIDENT WITH DIANEAL PD1, DIANEAL PD4 UNKNOWN BAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES (LOT NUMBERS NOT REPORTED) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS MANIFESTED AS ABDOMINAL PAIN, MURKY EFFLUENT AND CYTOSIS. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFAZOLIN 1.5GM AND CEFTAZIDIME 1.5GM IP FOR 24HRS. THE PATIENT ALSO RECEIVED "NIDAZYD", RIFAMPACINA AND PYRAZINAMIDE TREATMENTS. ON AN UNREPORTED DATE, DIANEAL PD4 WAS DISCONTINUED AND THE PATIENT IMPROVED FROM THE STERILE PERITONITIS AND CYTOSIS. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE STERILE PERITONITIS AND CYTOSIS. FROM (B)(6) 2010 TO (B)(6) 2010 AND FROM (B)(6) 2010 TO (B)(6) 2010 THE PATIENT WAS HOSPITALIZED FOR STERILE PERITONITIS. IT WAS NOT REPORTED WHETHER DIANEAL PD1, NUTRINEAL PD4 AND EXTRANEAL VIAFLEX WERE CONTINUED. THE PHYSICIAN BELIEVED THAT STERILE PERITONITIS AND CYTOSIS WAS RELATED TO DIANEAL PD4. THE PHYSICIAN BELIEVED THE ROOT CAUSE OF THE EVENTS WAS USE OF "BIO-INCONSISTENT FLUIDS (ENDOTOXINS)."

    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 70 YR Hospitalization| R CLEXANE (ENOXAPARIN)| DIANEAL PD4 , EXTRANEAL VIAFLEX AND NUTRINEAL| FUROSEMIDE (FUROSEMID), POLPRAZOL,| AVEDOL (CARVEDILOL), KALDYUM (POTASSIUM CHLORIDE)