BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2132914 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07788
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H11A19047 WITH NO ISSUES OR EXCEPTIONS NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A BATCH REVIEW WAS PERFORMED FOR H11B25034 AND AN EXCEPTION WAS NOTED FOR ARC IN FLUID PATH ASSOCIATED WITH THE CONNECTOR COMPONENT. THERE IS NO EVIDENCE TO SUPPORT ASSOCIATION TO THE REPORTED PROBLEM. THE AFFECTED PRODUCT WAS 100% INSPECTED. CORRECTIVE ACTIONS WERE IMPLEMENTED AND EFFECTIVE. QUALITY INSPECTIONS WERE ACCEPTABLE WITH ALL PRODUCT RELEASE REQUIREMENTS ACCEPTABLE. ROOT CAUSE WAS DETERMINED AS USER ERROR-POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USER ERROR-POOR ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE HOME PATIENT (HP) REGARDING AN UNRELATED ISSUE WHO STATED THAT THEY WERE CURRENTLY IN THE HOSPITAL, ADMITTED ON (B)(6) 2011 DUE TO PERITONITIS. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT THE HP WAS HOSPITALIZED FOR CULTURE POSITIVE (B)(6). ON (B)(6) 2011, BAXTER OBTAINED LAB CULTURE INFORMATION FROM ANOTHER PDRN. TREATMENT WAS INITIATED WITH LOADING DOSES OF CEFIPIME 1GM AND VANCOMYCIN 1250MG INTRAPERITONEALLY (IP) UPON ADMISSION, THEN SUBSEQUENT DAILY DOSES OF CEFTRIAXONE 1GM FOR 14DAYS. THE HP WAS DISCHARGED HOME ON (B)(6) 2011 AND TREATMENT CONTINUED FOR THE CLINIC. THE PDRN GAVE CAUSALITY AS THE HP FORGETTING TO WEAR A MASK WHEN CONNECTING AND USING POOR ASEPTIC TECHNIQUE.

    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 66 YR Hospitalization| R REGCAL(PD2) AMBUFLEX| LOCAL(PD4)ULTRABAG| HOME CHOICE