BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1850538 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03988
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A PATIENT SEPARATING LINES OF TUBING. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF 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 REPORT WAS MIS USE. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(6) REQUESTING ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC) UNIT. THE HP STATED HE TRIED USING THE SAME SUPPLIES AFTER NOTICING THE LINES SEEMED TO BE GLUED TOGETHER. THE HP STATED HE SEPARATED THE LINES AND RESTARTED THERAPY; HOWEVER, HE WAS UNABLE TO CONTINUE THERAPY. THE HP STATED HE NEEDED ASSISTANCE TO END THERAPY TO START OVER WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND REMOVE THE CASSETTE. THE HP CONFIRMED TO CALL BACK WITH ANY PROBLEMS. ON (B)(6) 2010, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP VIA PHONE CALL; THE HP STATED THAT HE DID NOT NOTICE ANYTHING UNUSUAL WITH THE CASSETTE. THE HP CONFIRMED THAT EVERYTHING WAS GOING WELL WITH THERAPY AND HE REPORTED NO FURTHER INCIDENT WITH HIS HOME CHOICE (HC). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR