BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 10804801 · Received November 6, 2020

    Report

    Report Number
    1416980-2020-06938
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 11, 2020
    Report Date
    November 6, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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 THAT A PERITONEAL DIALYSIS PATIENT EXPERIENCED ABDOMINAL FULLNESS, DYSPNEA AND BACK PAIN DURING DWELL 2 OF 4. THE PATIENT WAS CONNECTED TO A HOME CHOICE DEVICE AND WAS PERFORMING THERAPY AT THE TIME OF THE EVENT. THE INITIAL DRAIN ALARM (IDA) WAS SET AT 850 ML WITH A LAST FILL VOLUME (LFV) OF 1500 ML. THE IDA WAS <70% OF THE LFV REPRESENTING A USER ERROR. THE PATIENT WAS ASSISTED TO PERFORM A MANUAL DRAIN OF 3700ML WITH RELIEF OF SYMPTOMS. THE CAREGIVER REPORTED THAT THE PATIENT HAD MID-THERAPY EXCHANGES OF MANUAL 200ML DIANEAL 4.25% BECAUSE THEY RAN OUT OF SUPPLIES. THE CAREGIVER WAS ASSISTED IN ENDING THERAPY, AND WAS ADVISED TO CALL THE NURSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269032 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other