BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3881160 · Received June 18, 2014

    Report

    Report Number
    1416980-2014-19385
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 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). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A CLAMP BEING LEFT OPEN ON UNUSED LINES IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY WHEN PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. 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

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DWELL TWO. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THEY DISCONNECTED IN DAY DWELL AND RECONNECTED TO THE HC. THE HP USED ASEPTIC TECHNIQUE FOR BOTH DISCONNECTING AND RECONNECTING TO THE HC. THE HP STATED THERE WAS AN UNUSED SUPPLY LINE CLAMP THAT WAS LEFT OPEN BUT CAPPED OFF. THE HP STATED WHEN THE HC ALARMED THEY DISCONNECTED FROM THE HC AND USED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) SUPPLIES. THE HP WOULD COMPLETE THE THERAPY WITH MANUAL EXCHANGE. 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
    358538 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR HOMECHOICE