BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1840335 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03585
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 28, 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). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH THE CAREGIVER (CG) WHO STATED THERAPY RESUMED BY STARTING WITH NEW SUPPLIES. NO DEFECTS WERE NOTED AT THE TIME AND THERE WERE NO SAMPLES OR LOT NUMBER TO PROVIDE. THE HP IS RESUMING THERAPY ON THE CYCLER WITHOUT FURTHER ISSUE. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS EVENT. AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CONNECTION ISSUE. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. A 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 CAREGIVER (CG) CONTACTED (B)(6) REQUESTING ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC) MACHINE. THE CG STATED THAT DURING PRIMING THE LINE CAME OUT OF THE TOP SUPPLY BAG. THE CG STATED SHE WAS TRYING TO GET THE HC TO STOP BUT SHE ENDED UP PRESSING GO. THE CG STATED THE HC WAS IN INITIAL DRAIN AND SHE NEEDED TO SETUP WITH NEW SUPPLIES. THE CG CONFIRMED THE HOME PATIENT (HP) WAS NOT CONNECTED TO THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO SETUP WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 63 YR