BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3840679 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17399
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    August 15, 2012
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) EXPERIENCED A HEART ATTACK. THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PT WAS PERFORMING PD THERAPY AT THE TIME OF THE EVENT. FOUR DAYS AFTER HOSPITALIZATION, THE PT WAS DISCHARGED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319658 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX