BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2122753 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07560
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 23, 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

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS, INCREASED ABDOMINAL GIRTH AND DIFFICULTY BREATHING IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO PERITONITIS MANIFESTED BY POOR DRAIN, DIFFUSE ABDOMINAL PAIN AND CLOUDY EFFLUENT, AND ALSO EXPERIENCED INCREASED ABDOMINAL GIRTH WITH DIFFICULTY BREATHING. THE PATIENT WAS TREATED WITH AMIKACIN AND VANCOMYCIN (NOT FURTHER SPECIFIED). THE OUTCOME OF THE EVENTS OF PERITONITIS, INCREASED ABDOMINAL GIRTH, AND DIFFICULTY BREATHING WERE NOT REPORTED. ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENTS OF PERITONITIS, INCREASED ABDOMINAL GIRTH, DIFFICULTY BREATHING AND THE RELATION TO DIANEAL PD2 UNKNOWN BAG THERAPY.

    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 49 YR Hospitalization| R DIANEAL PD2