BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3812654 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15594
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A23038, H14B05058, AND H14B26070 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER - THE PATIENT WAS PRESCRIBED TWO PRODUCT CODES FOR THIS PRODUCT. IT IS UNKNOWN WHICH PRODUCT CODE WAS IN USE AT THE TIME OF THE EVENT. WHILE TWO PRODUCT CODES HAD BEEN PRESCRIBED TO THE PATIENT, BOTH ARE FOR THE SAME BRAND NAME AND HAVE THE SAME 510(K) NUMBER. AS SUCH, THESE WERE PROVIDED. A BATCH REVIEW WILL BE PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A23038, H14B05058, AND H14B26070. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND BEGAN TREATMENT WITH VANCOMYCIN (INTRAPERITONEALLY, FOR 8 DAYS, DOSE AND FREQUENCY UNKNOWN) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER FIVE DAYS. PD THERAPY WAS ONGOING. THE CAUSE OF PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290932 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R HOMECHOICE, MINICAP, MINICAP TRANSFER SET, DIANEAL