BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2900377 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00438
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    June 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A CLINICAL REPORT FROM A HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A SUBJECT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. ON (B)(6) 2012, THE SUBJECT SIGNED THE INFORMED CONSENT AND WAS RANDOMIZED TO THE PD GROUP. ON (B)(6) 2012, THE SUBJECT'S PERITONEAL FLUID WAS TURBID. THE SUBJECT WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS ON THE SAME DATE. REMEDIAL TREATMENT WITH INTRAVENOUS CEFAZOLIN AND CEFTAZIDIME WAS INITIATED ON (B)(6) 2012 FOR PERITONITIS. ON (B)(6) 2012, CEFTAZIDIME WAS DISCONTINUED. ON (B)(6) 2012, CEFAZOLIN WAS DISCONTINUED. ON (B)(6) 2012, THE SUBJECT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE INVESTIGATOR ASSESSED THE EVENT AS MODERATE IN SEVERITY/INTENSITY. THE PERITONITIS WAS NOT DUE TO TRIAL PROCEDURE AND THE INVESTIGATOR DID NOT PROVIDE AN ALTERNATIVE ETIOLOGY. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6781 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R DIANEAL PD2 LACTATE- G 1.5%| NIFEDIPINE