BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4200477 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37305
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PERITONITIS HAS BEEN UPDATED TO BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT HAS BEEN CORRECTED FROM UNKNOWN TO USER ERROR - BREACH IN ASEPTIC TECHNIQUE. BEGINNING ON THE SAME DAY AS ADMISSION TO THE HOSPITAL, THE PATIENT RECEIVED CEFAZOLIN (TWO GRAMS PER DAY, DURATION SIX DAYS, ROUTE NOT REPORTED) AND INTRAPERITONEAL (IP) GENTAMYCIN (80 MILLIGRAMS PER DAY, DURATION SIX DAYS) FOR BACTERIAL PERITONITIS. EIGHT DAYS AFTER ADMISSION, THE PATIENT RECEIVED VANCOMYCIN (ONE GRAM PER DAY, DURATION NINETEEN DAYS) AND AMIKACIN (300 MILLIGRAMS PER DAY, DURATION NINETEEN DAYS) IP FOR BACTERIAL PERITONITIS. TWENTY-EIGHT DAYS AFTER ADMISSION TO THE HOSPITAL, DIANEAL THERAPIES WERE DISCONTINUED. THIRTY-EIGHT DAYS AFTER ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS IS UNKNOWN. TWO DAYS LATER, THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. TREATMENT FOR THIS EVENT WAS NOT REPORTED. PERITONEAL DIALYSIS THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME FROM THIS EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678372 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization DIANEAL 1.5% PD4, DIANEAL 2.5% PD4| DIANEAL, TITANIUM ADAPTER, MINICAP