BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3790807 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14492
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, IT WAS CLARIFIED THAT THE PATIENT HAD NOT USED PROPER DISCONNECT PROCEDURES WHEN THEY DISCONNECTED FROM THE PATIENT LINE. 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 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) DEVICE DURING DRAIN 3 OF 4 OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HP WAS CONNECTED. THE REPORTER STATED THAT THE HP HAD MISTAKENLY THOUGHT THERAPY WAS OVER AND DISCONNECTED. THEY THEN RECONNECTED AFTER REALIZING THERAPY WAS NOT OVER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE HP HAD USED THE PROPER DISCONNECTION AND RECONNECTION PROCEDURE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE REPORTER IN ENDING THE HP'S THERAPY AND REMOVING THE CASSETTE. THE HP WOULD COMPLETE THERAPY USING MANUAL SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267246 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1