BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL-DISOSABLE

    MDR report key: 1973463 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01285
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (SE) 2240 ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. 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). THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. 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 A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM DURING DWELL 5 OF 5 ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) REPORTED HE HAD THE SE 2240 AND CYCLED THE POWER AND THE HC ALARMED AGAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF HE WAS STILL CONNECTED. HP REPORTED HE WAS. THE TSR HAD THE HP CLOSE THE CLAMPS AND DISCONNECT. THE TSR EXPLAINED THE ALARM AND HP ADVISED HE DID NOT HAVE MANUAL SUPPLIES. TSR RECOMMENDED THAT THE HP CONTACT THE NURSE ABOUT THE ALARMS. THE CAUSE OF THE ALARM WAS UNDETERMINED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL-DISOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION - RENAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PERITONEAL DIALYSIS CYCLER