BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1893900 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05501
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE SYSTEM ERROR 2240 ALARM WAS UNDETERMINED. 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).

    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 510 NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. 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

    THIS IS A CASE REPORT RECEIVED THROUGH THE (B)(6) THROUGH BAXTER'S AFTERHOURS CALL SERVICE ON (B)(6) 2010 FROM A MALE PATIENT (B)(6), WHO ATTENDS (B)(6) HOSPITAL. IT WAS REPORTED THAT ON (B)(6) 2010 THE HOMECHOICE MACHINE SOUNDED A 2240 ALARM (AIR IN SET) DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED AT THE TIME OF THE REPORTED EVENT AND DID NOT DISCONNECT AT ANY TIME PRIOR TO THE EVENT. ALL BAGS WERE PROPERLY SPIKED AND CONNECTED. NO PATIENT EXTENSION LINES WERE USED. NO OPEN CLAMPS WERE NOTICED ON ANY UNUSED SUPPLY LINES. THE PATIENT DID NOT NOTICE ANYTHING UNUSUAL ABOUT THE SUPPLIES EITHER. THE PATIENT WILL START OVER WITH NEW SUPPLIES. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED. NO SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1