BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2884090 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07974
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4).BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6), INVOLVING BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR END STAGE RENAL DISEASE (ESRD). IT WAS REPORTED THAT DIANEAL WAS WITHDRAWN. EXTRANEAL REMAINED ONGOING WITH DOSE NOT CHANGED. ON AN UNREPORTED DATE, THE CONSUMER REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT EXPERIENCED A BACTERIAL PERITONITIS, WHICH WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT BEGAN REMEDIAL TREATMENT WITH CEFTRIAXON (2G, 1 TIME PER DAY, IP) AND CIPROFLOXACIN ( 2X 500MG, 1 TIME PER DAY, PER OS). THE REMEDIAL TREATMENT REMAINED ONGOING AND THE PATIENT REMAINED HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R EXTRANEAL| DIANEAL PD4 2.27%