BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2833266 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05210
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT, FOR THE UNKNOWN TRANSFER SET, IS 4 OF 4 INVOLVED IN THIS PERITONITIS INCIDENT. A REVIEW OF THE FACILITY'S ORDER HISTORY HAS SHOWN FOUR LOT NUMBERS (H12A31066, H12C30049, H12E29053 AND H12E21068) RECEIVED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR THESE LOTS, WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE, WITH NO EXCEPTIONS NOTED FOR THE BATCHES. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SPONTANEOUS REPORT BY A NURSE IN THE USA. THIS REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE EVENT OF INFECTION, FURTHER CLARIFIED BY THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) AS PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. THE RN STATED THAT THE CAUSE OF THE PERITONITIS WAS UNKNOWN, AND THE PATIENT DID RECEIVE SOME RE-TRAINING TO ENSURE THAT THE CAUSE WAS NOT RELATED TO TECHNIQUE. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH INTRA-PERITONEAL ANCEF AND FORTAZ (DOSES, LOT NUMBERS, NO FURTHER SPECIFICS WERE PROVIDED). THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DIANEAL