BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031877 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03736
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): AS PATIENT DISCARDS SUPPLIES AFTER EACH USE AND THE EXACT DATE OF THIS PERITONITIS IS UNKNOWN, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE FEBRUARY INCIDENT OF PERITONITIS IS BEING REPORTED UNDER REPORT #1423500-2011-02808. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS

    Description of Event or Problem · 1

    DURING A CALL ON (B)(6) 2011 THE NURSE REPORTED THAT HE WAS AWARE OF THE PATIENT DROPPED THE PATIENT LINE AS THE PATIENT TENDS TO DO THIS REGULARLY. HE ALSO REPORTED THAT THE PATIENT HAD PERITONITIS IN (B)(6) AND THEN AGAIN IN (B)(6) (DATES UNKNOWN). DURING A FOLLOW UP CALL WITH THE PERITONEAL DIALYSIS (PD) RN ON (B)(6) 2011 , SHE REPORTED THE PATIENT HAD PERITONITIS COINCIDENT WITH ICODEXTRIN AND LOCAL PD4 AMBUFLEX THERAPY IN (B)(6) 2011 AND THEN AGAIN IN (B)(6) 2011. ON AN UNKNOWN DATE IN (B)(6) 2011 PD CULTURES GRAM STAINS AND CELL COUNTS WERE DONE. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EPISODE OF PERITONITIS. ON UNREPORTED DATES IN (B)(6) 2011 THE PATIENT WAS TREATED WITH VANCOMYCIN 2GMS AND RECOVERED FROM THIS INCIDENCE OF PERITONITIS. THE PATIENT WAS REINSTRUCTED ON PROPER ASEPTIC TECHNIQUE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention HOME CHOICE CYCLER| ICODEXTRIN| LOCAL PD4 AMBUFLEX