BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2256804 · Received September 21, 2011

    Report

    Report Number
    1423500-2011-12457
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE NURSE. THE NURSE REPORTED A BREACH IN ASEPTIC TECHNIQUE (USE ERROR) DESCRIBED AS THE HOME PATIENT (HP) NOT WEARING A MASK AND NOT CLEANING THE AREA BEFORE STARTING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT THEN EXPERIENCED PERITONITIS. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE USE ERROR, THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H11F03123, H11E05047, H11D06071, AND H11D11089 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    INITIALLY THE PERITONEAL DIALYSIS (PD) HOME PATIENT'S (HP) CAREGIVER (CG) CONTACTED BAXTER TECHNICAL SERVICE AND REPORTED THAT THE HP IS TRAVELING AND HAD TO GO INTO THE HOSPITAL BECAUSE OF PERITONITIS. ON (B)(6) 2011 BAXTER PRODUCT SURVEILLANCE (PS) FOLLOWED UP ON THE REPORT OF PERITONITIS WITH THE PATIENT'S PERITONEAL DIALYSIS NURSE (PDN). THE FOLLOWING INFORMATION WAS OBTAINED. THE PDN CONFIRMED THE HP WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011 AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN 2.5 GM Q 5. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PDN REPORTED THAT THE HP HAS RECOVERED FROM THE EVENT OF PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PDN REPORTED THAT THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE DUE TO THE HP NOT WEARING A MASK AND NOT CLEANING THE AREA BEFORE STARTING PD THERAPY. THE PDN STATED THAT RETRAINING IN PROPER ASEPTIC TECHNIQUE WAS DONE. THE PDN CONFIRMED THAT THE CAUSE OF THE PERITONITIS WAS NOT RELATED TO A BAXTER PD SOLUTION OR A BAXTER PD DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R EXTRANEAL ICODEXTRIN| DIANEAL LOW CA 2.5%