BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2991613 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05434
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS REPORT OF PERITONITIS CAUSED BY USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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 ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD), WHICH LED TO BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT BEGAN REMEDIAL TREATMENT WITH CEFTAZIDIME (250 MG, INTRAPERITONEALLY (IP), 3 TIMES A DAY) AND CEFAZOLIN (250 MG, IP, 3 TIMES A DAY) FOR FIVE DAYS AND THEN THE PATIENT BEGAN TREATMENT WITH AMPICILLIN (250 MG, IP, 3 TIMES A DAY) FOR 14 DAYS. THE PATIENT WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUE. THE PATIENT WAS NOT HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94835 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ADALAT CR 30 (NIFEDIPINE)| EXTRANEAL| PHYSIONEAL| ERYTHROPOIETIN BETA| FOLICIL (FOLIC ACID)| B COMPLEX