BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL- DISPOSABLE

    MDR report key: 1871822 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04472
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABELING WAS FOUND ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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). UPDATED TO REFLECT SAMPLE UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE IS UNKNOWN; SHOULD THE PRODUCT CODE BE IDENTIFIED AT A LATER DATE OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) REPORTED SHE PRESSED GO TO START THERAPY BEFORE CONNECTING TO THE HC. HP THEN CONNECTED TO THE MACHINE AFTER THE HC STARTED TO ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP CLOSE ALL THE CLAMPS AND CYCLE POWER TO CLEAR THE ALARM. TSR EXPLAINED THE ALARM AND REVIEWED PROPER PROCEDURES PER THE USER MANUAL. TSR ALSO INSTRUCTED HP TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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