BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1920208 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06748
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLES NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE PRODUCT CODE IS UNKNOWN; THEREFORE, THE 510K NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION FOR THE SE 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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)(4) THROUGH BAXTER'S AFTER-HOURS CALL SERVICE ON (B)(4) 2010 FROM ((B)(6)) A MALE HOME PATIENT (HP) REPORTED THAT ON (B)(6) 2010 THE HOMECHOICE MACHINE SOUNDED A 2240 ALARM (AIR IN SET) DURING DRAIN 2/5. THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE ALARM AND DIDN'T DISCONNECT AT ANY TIME PRIOR TO THE ALARM. ALL BAGS WERE PROPERLY SPIKED AND CONNECTED. NO PATIENT EXTENSION LINES WERE USED. THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. NOTHING UNUSUAL WAS NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP WITH GETTING THE SET OUT. THE HP STATED THAT HE WILL FINISH THE THERAPY WITH MANUAL BAGS. 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 FKX

    Patients

    Seq Age Sex Outcome Treatment
    1