BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3130232 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13383
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS DID NOT WEAR MASK AND TOUCH CONTAMINATION DURING PERITONEAL DIALYSIS THERAPY. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL 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 THE PATIENT EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS DID NOT WEAR A MASK AND TOUCH CONTAMINATION DURING PERITONEAL DIALYSIS (PD) THERAPY WITH UNKNOWN BAXTER DISPOSABLES. A WEEK AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR 4 DAYS. THE PATIENT WAS TREATED WITH VANCOMYCIN 1 GRAM INTRAPERITONEALLY (IP) THREE TIMES WEEKLY. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230873 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R HOMECHOICE| DIANEAL UNKNOWN ULTRABAG| DIANEAL PD4 AMBUFLEX 2.5%