BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2892867 · Received January 2, 2013

    Report

    Report Number
    1416980-2013-00037
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A 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. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE (GPV) FROM A BAXTER EMPLOYED HEALTH PROFESSIONAL. ON (B)(4) 2012, TREATMENT WITH CEFAZOLINE AND GENTAMYCIN WAS STOPPED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON THAT SAME DAY, THE PATIENT RECOVERED FROM THE PERITONITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 1.5% SOLUTION THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). DIANEAL THERAPY WAS ONGOING. DURING A CALL, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFEST BY CLOUDY EFFLUENT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT WAS TREATED WITH CEFAZOLIN AND GENTAMYCIN. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS. PER THE HEALTHCARE PROFESSIONAL, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL PD4 1.5%