BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 16763182 · Received April 18, 2023

    Report

    Report Number
    1416980-2023-01813
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL OF THE DEVICE. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL SPECIFICATION REQUIREMENTS PER RITE TESTING. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED, AND NO ISSUES WERE NOTED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EVENT HISTORY LOG REVIEW SHOWED THE PROGRAMMED I-DRAIN ALARM (0ML) MAY HAVE BEEN SET TOO LOW FOR THE MOST RECENT THERAPIES. PER THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE, IF THE PATIENT HAS FLUID IN THEIR PERITONEAL CAVITY AT THE BEGINNING OF THERAPY, EITHER DUE TO THE PREVIOUS THERAPY¿S LAST FILL VOLUME OR AN OFF-CYCLER EXCHANGE, THEN THE I-DRAIN ALARM SHOULD NOT BE SET TO ZERO (0) OR OFF. THE RECOMMENDED PRACTICE IS TO SET THE I-DRAIN ALARM TO AT LEAST 70% TO 95% OF THE LAST FILL OR 70% TO 95% OF THE LAST OFF-CYCLER FILL VOLUME, DEPENDING ON THE LAST FILL SOLUTION TYPE DELIVERED. THE REPORTED CONDITION WAS NOT VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE THE PROGRAMMED I-DRAIN ALARM BEING SET TOO LOW FROM AN OFF-CYCLER EXCHANGE. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE WARNS THAT ¿SETTING THE I-DRAIN ALARM VOLUME TOO LOW OR OFF CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION.¿ SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED TROUBLE BREATHING, ABDOMINAL PAIN, BLOATING AND FULLNESS DURING DRAIN AND DWELL ONE. THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENTS. THE PATIENT REPORTED THAT THE IDA WAS SET TO 0 ML AND THE DEVICE ¿GETS OVERFILLED¿. THE REPORTED STATED THEY REQUESTED A SWAP OF THE DEVICE. THE PATIENT STATED THEY WERE INFORMED THAT THE DEVICE WAS OPERATIONAL, AND THE IDA NEEDS TO BE SET "TO SOMETHING OTHER THAN 0 ML". THE PATIENT CALLED THE PD RN, AND REPORTEDLY THE RN REFUSED TO CHANGE THE IDA. THE PATIENT PERFORMED A MANUAL DRAIN LEAVING 1500 ML. RENAL THERAPY SERVICES (RTS) INITIATED THE SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093060 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other