BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2991615 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05435
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. PER THE CUSTOMER, THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THE 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SYSTEM ERROR (SE) 2240 SOUNDED DURING DWELL 6 OF 7 ON THE HOMECHOICE (HC) MACHINE. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE USED AND WERE CONNECTED PRIOR TO PRIMING. THE PATIENT DID NOT DISCONNECT PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. PROPER DISCONNECT PROCEDURES WERE NOT USED. THE PATIENT RECONNECTED. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. IT WAS UNKNOWN HOW THE HOME PATIENT (HP) WOULD COMPLETE THERAPY. THE HC WAS OPERATIONAL. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. THERE WERE NO REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95565 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE