BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233914 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11695
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A AIR IN TUBING WITHOUT ALARM WAS CONFIRMED BECAUSE THE USER DID NOT CHECK THE PATIENT LINE FOR AIR BEFORE STARTING THERAPY. DURING INITIAL DRAIN THE PATIENT OBSERVED AIR IN THE LINE. USERS ARE INSTRUCTED TO CHECK THE PATIENT LINE AFTER PRIMING TO ENSURE THE FLUID IS NEAR THE CONNECTOR AND THERE IS NO AIR IN THE LINE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AIR IN THE PATIENT LINE WHILE ON THE HOMECHOICE MACHINE. THE HOME PATIENT (HP) STARTED THERAPY AND DID NOT CHECK THE PATIENT LINE FOR AIR. THE HP WAS IN THE INITIAL DRAIN AND THERAPY WAS AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY AND THE HP WOULD RESTART THE SETUP WITH ALL NEW SUPPLIES. PRODUCT SURVEILLANCE (PS) CONTACTED THE HP ON (B)(4) 2011 REGARDING THE AIR IN THE TUBING. THE HP STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY. PS ADVISED THE HP TO MAKE SURE THE LINES ARE CHECKED FOR AIR PRIOR TO CONNECTION AND THE HP UNDERSTOOD. THE HP DID NOT FOLLOW UP WITH HER PERITONEAL DIALYSIS NURSE ABOUT THE AIR IN THE LINE. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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