BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1971141 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01055
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    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 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) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS SPECIES, COAGULASE NEGATIVE IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY INTRAPERITONEALLY (IP) FOR AUTOMATED PD (APD) FOR END STAGE RENAL DISEASE (ESRD). ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. THE NURSE REPORTED "THE PATIENT HAD BEEN COUGHING ON THE CONNECTIONS." ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED, AND EXTRANEAL THERAPY WAS TEMPORARILY WITHDRAWN WHILE THE PATIENT RECEIVED CONTINUOUS AMBULATORY PD (CAPD). ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH ZINACEF 250 MG/2 L TWICE IP. ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH ZINACEF 250 MG/2 L TIMES FOUR IP, AND HEPARIN TIMES THREE IP. ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH ZINACEF 250 MG/2 L TIMES FOUR IP AND HEPARIN ONCE IP. ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH ZINACEF 250 MG/2L ONCE IP, AND VANCOMYCIN 1 GM/2 L ONCE IP. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS, AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE PATIENT RECEIVED VANCOMYCIN 2 GM/2 L ONCE IP AS PREVENTIVE TREATMENT. ON (B)(6) 2011, THE PATIENT RESTARTED TREATMENT WITH EXTRANEAL VIAFLEX. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BACTERIAL PERITONITIS IN RELATION TO EXTRANEAL 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 Hospitalization| R EXTRANEAL VIAFLEX| PD CYCLER