BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1423500-2011-00653

    MDR report key: 1961792 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00653
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 27, 2010
    Report Date
    December 3, 2010
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO THE PATIENT HAVING A CLAMP OPEN ON A SUPPLY LINE NOT CONNECTED TO A SOLUTION BAG. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IDENTIFIED IN THE COMPLAINT. 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). DURING INVESTIGATION BY BAXTER IT WAS DETERMINED THAT THIS INCIDENT WAS CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 ON THE HOMECHOICE (HC) MACHINE DURING DWELL 3. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE ALL CLAMPS AND TRANSFER SET. WHILE IN DWELL 3, THE HP LEFT 2 SPARE CLAMPS OPEN CAUSING THE ALARM . THE TSR ADVISED THE HP TO DISCARD ALL SUPPLIES AND TO REPORT THE ALARMS TO THE NURSE. THE HP WILL FINISH TONIGHT'S THERAPY MANUALLY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER