BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3122926 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13070
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12L09045 WAS COMPLETED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HOME PATIENT EXPERIENCED PERITONITIS SECONDARY TO AN ONGOING (B)(6) INFECTION. PER THE REGISTERED NURSE (RN) THE HOME PATIENT (HP) WAS ADMITTED TO THE HOSPITAL FROM HOME WITH C-DIFF AND DEVELOPED A TRANSMURAL INFECTION RESULTING IN PERITONITIS (BOTH PRESENT BEFORE ADMISSION). THE HP WAS TREATED IN THE HOSPITAL WITH VANCOMYCIN (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED), INTRAPERITONEALLY (IP) AND GENTAMYCIN IP (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED). THE HP WAS DISCHARGED TO A NURSING HOME (DATE UNKNOWN) FOR CONTINUED THERAPY. THE PERITONITIS IS RESOLVED, HOWEVER THE C-DIFF IS STILL PRESENT. THE HOME PATIENT IS STILL ON PERITONEAL DIALYSIS THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224092 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL