BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3023350 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07418
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT'S TECHNIQUE WAS OBSERVED IN THE PD CLINIC. THE PATIENT WAS NOTED TO PUT HER MASK ON AND RUN HER HANDS THROUGH HER HAIR AFTER WASHING HER HANDS. SHE ALSO PERFORMED HER EXCHANGES VERY RAPIDLY. THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE CAUSE AND OUTCOME OF THE BREACH IN ASEPTIC TECHNIQUE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124991 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR HOMECHOICE, DIANEAL PD4 ULTRABAG| EXTRANEAL VIAFLEX