BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3830037 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16782
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ON AN UNREPORTED DATE IN (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A USE ERROR THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN IP (EVERY 5 DAYS, DOSE NOT REPORTED) AND GENTAMYCIN IP (DAILY FOR 21 DAYS, DOSE NOT REPORTED) FOR PERITONITIS. ON UNREPORTED DATES, THE PATIENT EXPERIENCED TWO MORE EPISODES OF RECURRENT PERITONITIS. AGAIN, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN IP (EVERY 5 DAYS, DOSE NOT REPORTED) AND GENTAMYCIN IP (DAILY FOR 21 DAYS, DOSE NOT REPORTED) FOR BOTH RECURRENT PERITONITIS EPISODES. ON AN UNREPORTED DATE FIVE MONTHS AFTER THE FIRST ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. THE PATIENT¿S PD CATHETER WAS REMOVED AND DIANEAL THERAPY WAS DISCONTINUED. THE PATIENT CONTINUED WITH AN UNKNOWN INTRAVENOUS (IV) ANTIBIOTIC FOR 2 WEEKS AFTER PD CATHETER WAS REMOVED FOR PROPHYLAXIS. ON AN UNREPORTED DATE, THE PATIENT STARTED HEMODIALYSIS. THE PATIENT RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308735 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5% AND 2.5% AMBUFLEX