BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2296342 · Received October 14, 2011

    Report

    Report Number
    1423500-2011-13491
    Event Type
    Injury
    Date Received
    October 14, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 26, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT FROM A CONSUMER FROM (B)(6) OF BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6) 2011, THE PATIENT EXPERIENCE BACTERIAL PERITONITIS MANIFESTED BY TURBID YELLOW DIALYSATE EFFLUENT, ABDOMINAL PAIN AND A FEVER. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE BACTERIAL PERITONITIS. THE RESULTS OF THE CULTURE WERE BACTERIAL. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL TREATMENT WITH AMIKACIN 12 MG/L INCORPORATED IN PD SOLUTION. AS OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED WITH THE EVENT OF BACTERIAL PERITONITIS ONGOING AND IMPROVED. THE OUTCOME OF THE FEVER WAS NOT REPORTED. PD THERAPY WAS ONGOING. THE CONSUMER OPINION OF CAUSALITY WAS UNKNOWN FOR THE BACTERIAL PERITONITIS AND NOT REPORTED FOR THE FEVER. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG