BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3780985 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-13971
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR WHERE THE HOME PATIENT STATED THAT THE PATIENT LINE DID NOT PRIME BUT HE HOOKED UP ANYWAY. 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. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. 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. ALSO, IT WARNS THE USER THAT CONNECTING THE TRANSFER SET TO THE PATIENT LINE BEFORE CONNECT YOURSELF APPEARS ON THE DISPLAY SCREEN MAY RESULT IN INCREASED INTRA-PERITONEAL VOLUME (IIPV) OR CAN CAUSE AIR TO BE DELIVERED TO THE PERITONEAL CAVITY. A 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 THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING USE; PATIENT CONNECTED IN INITIAL DRAIN. THE HP STATED THAT THE PATIENT LINE WAS NOT PRIMED WHEN THE HP CONNECTED. THE HP WAS USING A PATIENT LINE EXTENSION. THE HP CYCLED THE POWER TO CLEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE TSR ADVISED THE HP NOT TO CONNECT UNLESS THE PATIENT LINE WAS PRIMED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260436 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE