BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3831107 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16915
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WILL BE PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER(S) H14B08037. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESS. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308929 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization CASSETTE| HOMECHOICE, TRANSFER SET, DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX