BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123298 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33488
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE AN INCOMPLETE CONNECTION. 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 INSTRUCTS THE USE ON HOW TO CONNECTION THE SOLUTION BAGS, INCLUDING THE HEATER BAG. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT THE CASSETTE HAD BECOME DISCONNECTED FROM THE HEATER BAG. THIS OCCURRED DURING FILL 1 OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE REGISTERED NURSE (RN) IN ENDING THE HP¿S THERAPY BY CYCLING THE POWER ON THE HC DEVICE. THE RN PLANNED TO START THE HP¿S THERAPY OVER USING NEW SUPPLIES. DURING FOLLOW-UP WITH THE RN, IT WAS FOUND THAT THE DISCONNECTION WAS DUE TO A POOR CONNECTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602732 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO DIANEAL SOLUTION BAG| HOMECHOICE PRO