BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1923408 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06845
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 22, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND ON (B)(6) 2010, RECEIVED REMEDIAL THERAPY WITH A LOADING DOSE OF VANCOMYCIN 2GM INTRAPERITONEALLY (IP) AND FORTUM 250MG IP TWICE DAILY. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010. AT THE TIME OF THIS REPORT, THE ANTIBIOTIC THERAPY AND THE DIANEAL PD2 ULTRABAG THERAPY WERE ONGOING; AND THE PATIENT WAS STILL HOSPITALIZED. THE OUTCOME OF THE EVENT OF PERITONITIS WAS REPORTED AS UNKNOWN. THE CONSUMER REPORTED IT WAS HIS OPINION THE PERITONITIS WAS NOT RELATED TO THE DIANEAL PD2 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 56 YR Hospitalization| R DIANEAL PD2 ULTRABAG