BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 4110022 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32795
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CARDIAC AND RESPIRATORY ISSUES COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR UNSPECIFIED ¿CARDIAC AND RESPIRATORY ISSUES¿. TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE WHEN THE ISSUES OCCURRED. THE OUTCOME OF THE EVENT WAS NOT REPORTED AND AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590535 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization