BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3122783 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13050
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION DURING PD 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 THAT A PATIENT EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION DURING PERITONEAL DIALYSIS (PD) THERAPY WITH UNKNOWN BAXTER DISPOSABLES. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS FOR THE EVENT AND TREATED WITH UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTICS WHILE IN THE HOSPITAL. THE PATIENT CONTINUED ORAL DICLOXACILLIN AT HOME FOR PERITONITIS (DOSE AND FREQUENCY UNKNOWN). THREE WEEKS LATER, THE PATIENT WAS RE-HOSPITALIZED FOR RECURRENT PERITONITIS. THE PATIENT WAS RECOVERING FROM PERITONITIS WHEN SHE WAS READMITTED. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR RECURRENT PERITONITIS AND THE PD CATHETER HAD TO BE REPLACED. THE PATIENT WAS RETRAINED. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT WAS STILL HOSPITALIZED OR THE PATIENT'S RECOVERY STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224981 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL PD4 ULTRABAG