BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3905258 · Received July 1, 2014

    Report

    Report Number
    1416980-2014-21011
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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 THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PT MADE A MISTAKE AND EXPERIENCED A TOUCH CONTAMINATION (NOT FURTHER SPECIFIED). ON AN UNREPORTED DATE, THE PT WAS TREATED FOR THE PERITONITIS WITH VANCOMYCIN (IP) INTRAPERITONEALLY (DOSE AND FREQUENCY UNKNOWN). THREE DAYS AFTER ONSET OF THE PERITONITIS, THE PT WAS ADMITTED TO THE HOSPITAL FOR SIX DAYS DUE TO THE UNRESOLVED PERITONITIS EVENT. TREATMENT CONSISTED OF INTRAVENOUS (IV) VANCOMYCIN, WHICH WAS UNSUCCESSFUL (DOSE AND FREQUENCY NOT REPORTED). ON AN UNKNOWN DATE, PERITONEAL DIALYSIS (PD) THERAPY WAS DISCONTINUED. THREE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PT¿S CATHETER WAS SURGICALLY REMOVED. ON AN UNKNOWN DATE, THE PT BEGAN HEMODIALYSIS THERAPY. THE PT WAS NOT RETRAINED IN ASEPTIC PROCEDURES FOR PD THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT IS CURRENTLY NOT ON PD THERAPY AND THE PT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382070 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R DIANEAL PD4 2.5% AMBUFLEX| EXTRANEAL