BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970750 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01032
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 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 (B)(6) AND IS A SOLICITED REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PD4 ULTRABAG THERAPY INTRAPERITONEALLY (IP), FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, DURING A CALL TO BAXTER CUSTOMER SERVICES, THE PATIENT REQUESTED TO STOP HOME DELIVERY OF DIANEAL BECAUSE SHE EXPERIENCED PERITONITIS (ONSET DATE NOT REPORTED). REMEDIAL TREATMENT AND WHETHER LABORATORY TESTS WERE PERFORMED WAS UNKNOWN. AT THE TIME OF THIS REPORT, OUTCOME OF THE EVENT OF PERITONITIS WAS ONGOING AND UNCHANGED. ON AN UNREPORTED DATE, DIANEAL WAS DISCONTINUED DUE TO THE PERITONITIS. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 67 YR Other DIANEAL PD4 ULTRABAG