BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3941617 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23014
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A CARE GIVER (CG) REPORTED THAT THE HOME PATIENT (HP) CONNECTED TO THE PATIENT LINE BEFORE THE LINE WAS PROPERLY PRIMED. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING FOR A CHECK PATIENT LINE ALARM ON A HOMECHOICE (HC) DEVICE, A TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS INFORMED THAT THERE WERE GAPS OF AIR IN THE PATIENT LINE. THE AIR WAS OBSERVED DURING THE INITIAL DRAIN PHASE OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE HOME PATIENT (HP) WAS CONNECTED WHEN THE AIR WAS NOTED. TROUBLESHOOTING FOR THE OBSERVED AIR REVEALED THAT THE HP FAILED TO ALLOW THE PATIENT LINE TO PRIME PROPERLY PRIOR TO CONNECTING TO THE DEVICE. THE TSR INSTRUCTED A CARE GIVER (CG) TO RESTART THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419862 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR HOMECHOICE