BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2851048 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06123
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. 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. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT AND PERITONITIS, WHERE THE HEALTHCARE PROFESSIONAL REPORTED THE PATIENT REUSED EQUIPMENT. THE COMPLAINT IS CONFIRMED BECAUSE RE-USE OF EQUIPMENT IS A USE ERROR THAT CAN CAUSE CONTAMINATION. THE ASSIGNABLE CAUSE FOR THE REUSE OF SINGLE USE PRODUCT WAS NOT DETERMINED. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF THE USE ERROR IN THIS COMPLAINT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY BAXTER GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL (HP) FROM (B)(6) OF REUSED EQUIPMENT AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL 1.5% ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL 1.5% ULTRABAG THERAPY (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER (B)(4) TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT REUSED THE EQUIPMENT WHICH RESULTED IN PERITONITIS (DETAILS NOT PROVIDED). PER THE HP, THE PATIENT EXPERIENCED THE PERITONITIS ON (B)(6) 2012. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION VANCOTROY (2GM, IP, STAT AND REPEATED AFTER 7 DAYS) AND INJECTION GENTAMYCIN (20MG, IP, ONCE DAILY FOR 14 DAYS) FOR PERITONITIS. CONCOMITANT THERAPY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE HP STATED THE PATIENT WAS RECOVERING FROM THE PERITONITIS. PER THE HP, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF THE PATIENT REUSED EQUIPMENT. ON (B)(6) 2012 ADDITIONAL INFORMATION WAS RECEIVED BY BAXTER PRODUCT SURVEILLANCE FROM BAXTER (B)(4) CONFIRMING, ON AN UNSPECIFIED DATE, THE PATIENT WAS RE-TRAINED IN PROPER ASEPTIC PROCEDURES FOR PD THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention DIANEAL 1.5% ULTRABAG