BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2020787 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03272
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON (B)(6) 2011, THE PATIENT'S DIANEAL THERAPY WAS STOPPED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH CEFTRIAXON, 1GM, IV, ONCE DAILY. AT THE TIME OF THIS REPORT, THE OUTCOME FOR PERITONITIS WAS NOT REPORTED AND THE PATIENT REMAINED HOSPITALIZED. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS.

    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 51 YR Hospitalization| R KALIUM DURULE| DIANEAL PD2| FERROUS SULFATE