BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2971992 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04304
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE REPORT OF USE ERROR-BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IS CONFIRMED BASED ON THE NURSE'S REPORT. THE CAUSE WAS THE PATIENT DISCONNECTING THEMSELVES IMPROPERLY, WHICH CAUSED PERITONITIS. A LABELING REVIEW FOUND CURRENT US PATIENT AT-HOME GUIDE. DOCUMENT NUMBER: 07-19-61-244 - OCTOBER 2009, PAGE 3-1 INSTRUCTS USERS TO USE PROPER ASEPTIC TECHNIQUE. 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.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. THE PATIENT EXPERIENCED LOW OXYGEN LEVEL FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND GOT CONFUSED, WHICH CAUSED THE PATIENT TO HAVE A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT DISCONNECTED HIMSELF IMPROPERLY. THE PATIENT EXPERIENCED PERITONITIS CAUSED BY THE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS NOT HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLIN (DOSE AND FREQUENCY UNKNOWN). PD THERAPY WAS ONGOING. THE PATIENT RECOVERED FROM THE PERITONITIS AND THE CARE GIVER WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76900 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention HOMECHOICE, DIANEAL LOW CALCIUM AMBUFLEX