BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2780869 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01983
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. THIS REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED BECAUSE THE NURSE REPORTED THERE WAS A BREAK IN ASEPTIC TECHNIQUE BY THE USER. HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. INSTRUCTIONS RELATED TO THE REPORTED PROBLEM ARE CONTAINED IN THE PRODUCT LABELING, ARE ACCURATE AND SUFFICIENT, AND EASILY ACCESSIBLE BY THE PATIENT. NO ISSUES WERE IDENTIFIED WITH THE PRODUCT LABELING THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. 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 REPORT RECEIVED FROM GLOBAL PHARMACOVIGILANCE IS A SPONTANEOUS REPORT FROM A THE PATIENT'S DAUGHTER WITH SUPPLEMENTAL INFORMATION FROM A NURSE RECEIVED ON (B)(6) 2012 BY CUSTOMER SERVICES. ON (B)(6) 2012, THE PATIENT DEVELOPED A HEMO CATHETER INFECTION, CALCIPHYLAXIS AND WAS HOSPITALIZED ON THE SAME DAY. ON (B)(6) 2012, THE PATIENT EXPERIENCED AN INFECTION OF THE BLOOD. THE PATIENT'S DAUGHTER STATED THAT THE INFECTION OF THE BLOOD DEVELOPED SHORTLY AFTER THE AMPUTATION OF LEFT LEG. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THE EVENTS. A CAUSALITY ASSESSMENT FOR THE INFECTION OF THE BLOOD WAS NOT REPORTED. THE PERITONEAL DIALYSIS NURSE STATED THE HEMO CATHETER INFECTION AND CALCIPHYLAXIS WERE UNRELATED TO DIANEAL THERAPY. ON (B)(6) 2012, GLOBAL PHARMACOVIGILANCE RECEIVED THE FOLLOWING INFORMATION FROM THE NURSE REGARDING THE EVENT. THE NURSE CONFIRMED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED AN INFECTION OF THE BLOOD AS PREVIOUSLY REPORTED. THE ETIOLOGY OF INFECTION OF THE BLOOD WAS UNKNOWN. ON AN UNREPORTED DATE, THERE WAS A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH PERITONITIS CAUSED BY THE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) FOR PERITONITIS. THE PATIENT WAS RE-TRAINED ON HOW TO PROPERLY PERFORM THE PD THERAPY. THE PATIENT RECOVERED FROM PERITONITIS WITH CULTURE POSITIVE FOR MRSA AND INFECTION OF THE BLOOD WITH CULTURE POSITIVE FOR MRSA. THE NURSE STATED THE EVENTS WERE NOT RELATED TO DIANEAL THERAPY, A BAXTER DEVICE OR DISPOSABLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| HOMECHOICE