BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 9314921 · Received November 13, 2019

    Report

    Report Number
    1416980-2019-06302
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 19, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED DIFFICULTY BREATHING UNTIL DRAIN 1 OF 4 WAS COMPLETED. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PRO DEVICE AT THE TIME OF THE EVENT. IT WAS REPORTED A HIGH DRAIN 101 ALARM WAS GENERATED WITH A DRAIN VOLUME OF 4292 ML. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO MANUALLY DRAIN, AND IT WAS REPORTED DRAINING RELIEVED THE SYMPTOMS. THE INITIAL DRAIN ALARM (IDA) WAS SET AT 0ML WITH A LAST FILL VOLUME OF 2000 ML. RTS EXPLAINED THE IDA REQUIRES A SETTING GREATER THAN 0ML AND ADVISED THE PATIENT TO CONTACT THE REGISTERED NURSE REGARDING THE IDA SETTING. THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110989 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other