BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2082455 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05656
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 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). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H10K17059 AND H10L2204 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE OF THE PERITONITIS IS 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 FIRST OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE PERIONEAL DIALYSIS NURSE REGARDING AN UNRELATED ISSUE WHO STATED THAT THE HOMEPATIENT(HP) HAD BEEN HOSPITALIZED FOR PERITONITIS ON (B)(6) 2011-(B)(6) 2011. THE HP'S OUTCOME WAS ONGOING AT THE TIME OF THIS REPORT. THE NURSE STATED THE CAUSALITY WAS TOUCH CONTAMINATION.

    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 40 YR Hospitalization LOWCAL(PD4)AMBUFLEX| EXTRANEAL| HOMECHOICE| LOWCAL(PD4)ULTRABAG