BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2153743 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08787
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC) CASSETTE THAT WOULD NOT CONNECT TO A TRANSFER SET, WHICH OCCURRED DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE NURSE (RN) STATED THAT WHEN THEY WENT TO CONNECT THE PATIENT LINE TO THE TRANSFER SET THAT IT WOULD TWIST TO CONNECT, BUT THE TWO CONNECTORS KEPT TWISTING AND DIDN'T STOP. THE TSR HAD THE RN START OVER WITH ALL NEW SUPPLIES. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE STATED THE FOLLOWING: THE TRANSFER SET WAS FINE AS A NEW CASSETTE WAS USED AND IT THREADED PROPERLY. THE NURSE WAS NOT SURE IF A SAMPLE OR LOT NUMBER WAS AVAILABLE AND ADVISED BAXTER TO CONTACT THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE CAREGIVER ON (B)(6) 2011. THE CAREGIVER STATED THE FOLLOWING: THE TRANSFER SET WAS FINE AND IT SEEMED TO BE JUST THAT ONE CASSETTE AS THE REST FROM THE BOX WORKED FINE. THE SAMPLE WAS DISCARDED AND A COMPANION AND LOT NUMBER WERE NOT AVAILABLE AS THE REST OF THE BOX WAS USED FOR THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO HOME CHOICE