BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1892368 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05429
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. PER THE CUSTOMER, THE SAMPLE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S AFTER HOURS CALL SERVICE REGARDING A SYSTEM ERROR 2240 ALARM (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE DURING DWELL 1 OF 5. THE PATIENT WAS CONNECTED AT THE TIME OF THE REPORTED EVENT AND DID NOT DISCONNECT AT ANY TIME PRIOR TO THE EVENT. ACCORDING TO THE PATIENT, A SUPPLY BAG GOT DISCONNECTED AND THE SOLUTION WAS LEAKING ON THE FLOOR. THE PATIENT DISCARDED THE SAMPLES AND STARTED OVER WITH NEW SUPPLIES. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE PATIENT. NO SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE ERROR 1 WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1