BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3231243 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18741
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS UNKNOWN; HOWEVER, THIS ALARM CAN BE GENERATED DUE TO AN INCOMPLETE PRIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONNECTING BEFORE VERIFYING THAT THE PATIENT LINE IS PROPERLY PRIMED IS A USE ERROR ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE", WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND WARNS THE USER NOT TO CONNECT TO YOUR PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE GUIDE INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED AND PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR (SE) 2240 (AIR IN LINE). THIS OCCURRED DURING THE INITIAL DRAIN CYCLE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT THE PATIENT LINE OF THE CASSETTE WAS NOT PRIMED TO THE TOP. THE PATIENT OBSERVED AIR IN THE PATIENT LINE AFTER THEY REALIZED THAT THE LINE HAD BEEN PINCHED IN THE DOOR OF THE HOMECHOICE. THE TECHNICAL SERVICED REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN CLEARING THE ALARM AND ADVISED THEM TO START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331490 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE