BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2900462 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00461
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED 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. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4), ON (B)(4) 2012, THAT THE HOME CHOICE MACHINE (HC) WAS IN PRIME AND THE HOME PATIENT (HP) WAS NOT CONNECTED TO THE MACHINE. HP STATED THAT WHILE IN PRIME THERE SEEMED TO BE FLUID COMING OUT OF THE BOTTOM OF THE CASSETTE DOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER AND TAKE THE CASSETTE OUT AT LOAD THE SET. THE HP STATED HE DID NOT SEE A LEAK ANYWHERE IN THE CASSETTE AND HE RELOADED IT AND WENT THROUGH THE SETUP AND AGAIN IN PRIME FLUID STARTED DRIPPING FROM THE BOTTOM OF THE DOOR. HP STATED HE WAS GOING TO SETUP WITH NEW SUPPLIES AND CALL BACK IF ISSUE REOCCURRED. HC WAS OPERATIONAL. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7164 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE