BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2013571 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02998
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6), NAUSEA, AND VOMITING IN PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL UNKNOWN (LOT NUMBER NOT REPORTED) AND EXTRANEAL VIAFLEX (LOT NUMBER NOT REPORTED) THERAPIES. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN AND EXTRANEAL VIAFLEX (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN, NAUSEA, AND VOMITING. IT WAS NOT REPORTED WHETHER REMEDIAL THERAPY WAS RENDERED OR WHETHER DIANEAL AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. AT THE TIME OF REPORTING, THE EVENTS OF BACTERIAL PERITONITIS WITH CULTURE (B)(6) FOR (B)(6), NAUSEA, AND VOMITING WERE ONGOING AND IMPROVED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN STATED THAT THE BACTERIAL PERITONITIS WITH CULTURE (B)(6) FOR (B)(6) WAS NOT RELATED TO DIANEAL AND EXTRANEAL VIAFLEX THERAPY AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF NAUSEA AND VOMITING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL| EXTRANEAL VIAFLEX