BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3760094 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12701
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 26, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H14A16107. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE PERTAINING TO THE REPORTED EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS ONGOING. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATMENT INFORMATION WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237361 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FLEXICAP, EXTENSION SET| HOMECHOICE, DIANEAL PD4 2.5% AMBUFLEX, MINICAP