BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CLARIA

    MDR report key: 12723508 · Received October 29, 2021

    Report

    Report Number
    1416980-2021-06506
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K201867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED; HOWEVER, THE SHARESOURCE LOG FILES ASSOCIATED WITH HOMECHOICE CLARIA WERE REVIEWED. A REVIEW OF THE EVENT LOG NOTED THAT THE INITIAL DRAIN ALARM (IDA) SETTING WAS PROGRAMMED TOO LOW AT 0 ML. PER THE HOMECHOICE CLARIA APD SYSTEM PATIENT AT-HOME GUIDE IF THE PREVIOUS THERAPY ENDED EARLY FOR ANY REASON OR AN OFF-CYCLER EXCHANGE WAS PERFORMED, THERE MAY BE MORE FLUID IN YOUR PERITONEAL CAVITY THAN NORMAL. IF THIS OCCURS, THE IDA ALARM SETTING MAY BE TOO LOW. THE PROGRAMMED I-DRAIN ALARM SHOULD BE SET TO AT LEAST 70% OF THE PROGRAMMED LAST FILL VOLUME. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE PROBABLE CAUSE OF THE EVENT WAS DETERMINED TO BE THE PROGRAMMED I-DRAIN ALARM BEING SET TOO LOW. 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 FEELING ¿TOO FULL¿, SLIGHT SHORTNESS OF BREATH AND VERY BLOATED DURING DWELL 1. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. IT WAS REPORTED THE NIGHT PRIOR TO THE EVENT, THERAPY WAS ENDED DURING THE THIRD FILL WITH A TOTAL FILL OF 6112 ML AND TOTAL DRAIN OF 3992 ML. THE PATIENT PRESENTED TO HOSPITAL TO PERFORM A MANUAL FILL AND AN INITIAL DRAIN WAS PERFORMED WITH A DRAIN VOLUME OF 174 ML. THE PATIENT REPORTED THE CYCLE STARTED TO FILL, WHICH RESULTED IN THE PATIENT FEELING TOO FULL, SLIGHT SHORTNESS OF BREATH AND VERY BLOATED. A MANUAL DRAIN WAS PERFORMED WITH 6369 ML AND FILL VOLUME 2000 ML. THE PATIENT WAS INITIATED ON HEPARIN TREATMENT FOR FIBRIN. THE PATIENT REPORTED THE CAUSE OF THE EVENTS WAS DUE TO THE FIBRIN. THE PATIENT REPORTED DRAINING RELIEVED THE SYMPTOMS. THERAPY WAS ENDED. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. 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
    1621629 HOMECHOICE CLARIA SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other