BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2870129 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07125
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF USE ERROR - REUSE OF SINGLE-USE SUPPLIES WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 AND SYSTEM ERROR 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE HOME PATIENT (HP) MENTIONED A SUPPLY BAG HAD DISCONNECTED AND THAT THEY HAD RECONNECTED THE BAG, STARTING OVER WITH THE SAME SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD THE HP TO DISCONNECT AND DISCARD THE SUPPLIES. THE TSR TOLD THE HP TO CALL HIS REGISTERED NURSE. PROPER PROCEDURES WERE REVIEWED AND THE PATIENT WOULD COMPLETE THERAPY MANUALLY. THERE WERE NO SAMPLES AVAILABLE. THE LOT NUMBER WAS NOT AVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2012. SHE STATED THAT THE PATIENT HAD SPOKEN WITH HIS PRIMARY NURSE ABOUT THIS INCIDENT AND PROPER PROCEDURES. THERAPY HAS BEEN GOING WELL SINCE, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    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 80 YR HOMECHOICE