BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2000879 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02425
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 31, 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 LOT NUMBERS H10K13017 AND H10J10023 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    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 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS NURSE REPORT FROM (B)(6) OF "SHE CONTAMINATED HERSELF," PAIN AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY, INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE, "SHE CONTAMINATED HERSELF". ON (B)(6) 2011, THE PATIENT EXPERIENCED PAIN AND CLOUDY EFFLUENT. THAT SAME DAY, DIANEAL THERAPY WAS WITHDRAWN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PERITONITIS WAS RELATED TO THE BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS "SHE CONTAMINATED HERSELF". TREATMENT INFORMATION AND THE HOSPITAL DISCHARGE DATE WAS UNKNOWN. THE OUTCOME FOR THE EVENTS OF PAIN AND PERITONITIS WERE UNKNOWN. IT WAS NOT REPORTED WHETHER THE EVENT OF "SHE CONTAMINATED HERSELF" RESOLVED. ON AN UNKNOWN DATE, THE PATIENT BEGAN HEMODIALYSIS.

    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 39 YR Hospitalization DIANEAL PD4 AMBUFLEX