BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4210857 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37906
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT DURING PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE HOME PATIENT SAID THAT THEY WERE ON THE INITIAL DRAIN WHEN THEY RECEIVED A LOW DRAIN VOLUME ALARM AFTER WHICH, THEY BYPASSED THE INITIAL DRAIN. THE PATIENT WENT THROUGH A FILL CYCLE AND THEN INTO DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE INSTRUCTED THE PATIENT TO PERFORM A MANUAL DRAIN AND THE DRAIN VOLUME EQUALED 3919ML. THE PATIENT¿S FILL VOLUME EQUALED 2200ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693182 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE