BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2122785 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07562
    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
    VM
    Reporter Occupation
    NURSE

    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 USE ERROR-NON-COMPLIANCE

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF NON-COMPLIANCE, PERITONITIS, FEVER AND VOMITING IN A PATIENT COINCIDENT WITH DIANEAL FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMEN PAIN AND CLOUDY EFFLUENT, FEVER AND VOMITING. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. THE CAUSE OF THE EVENTS WAS REPORTED AS NON-COMPLIANCE. REMEDIAL TREATMENT INCLUDED UNSPECIFIED ANTIBIOTICS. OUTCOME OF THE EVENTS OF PERITONITIS, FEVER AND VOMITING WERE REPORTED AS ONGOING AND IMPROVED. OUTCOME FOR NON-COMPLIANCE WAS NOT REPORTED. DIANEAL THERAPY CONTINUED. CAUSALITY ASSESSMENT FOR THE EVENTS OF NON-COMPLIANCE, PERITONITIS, FEVER AND VOMITING TO DIANEAL WAS NOT REPORTED.

    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 Hospitalization| R DIANEAL