BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2213779 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10790
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE. 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

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL FREELINE SOLO PD4 1.5 AND DIANEAL FREELINE SOLO PD4 2.5 THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER TECHNICAL SERVICE THE CONSUMER REPORTED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED. IT WAS UNKNOWN IF THE PATIENT UNDERWENT ANY DIAGNOSTIC TESTING OR RECEIVED ANY REMEDIAL TREATMENT. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. DIANEAL THERAPY WAS TEMPORARILY WITHDRAWN. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY. THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION.

    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 65 YR Other DIANEAL FREELINE SOLO PD4 2.5| DIANEAL FREELINE SOLO PD4 1.5