BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071984 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05140
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE CARE GIVER (GC) ON (B)(4) 2011 REGARDING THE REPORTED PROBLEM. THE CG STATED THAT SHE BELIEVES THAT IT WAS A USE ERROR AS IT WAS THE FIRST WEEK FOR HER TO BE CARING FOR HER MOTHER ON DIALYSIS. THE CG STATED THAT THE HOME PATIENT (HP) WAS ABLE TO CONTINUE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THIS COMPLAINT IS FOR A CHECK SUPPLY LINE ALARM. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED IN THE LAB. THE ROOT CAUSE WAS NOT IDENTIFIED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. 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). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) TO TURN THE BAG OVER, CLAMPS WERE OPEN, FRANGIBLES WERE BROKEN, THERE WERE NO KINKS IN THE TUBING BUT THERE WERE AIR BUBBLES IN THE SUPPLY LINE. THE TSR HAD THE CG PULL THE LINES UP AND DOWN, AIR BUBBLES WERE NOT MOVING. THE TSR HAD THE CG USE A NEW BAG AND CONNECT TO THE EXTRA WHITE COLOR CLAMPS, BROKE THE FRANGIBLES AND WENT BACK TO PRIME, THE ERROR HAD CLEARED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR HOMECHOICE CYCLER