BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1873139 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04572
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AN INCOMPLETE PRIME. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT 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 INCIDENT WAS DUE TO USE ERROR. THE PERITONEAL DIALYSIS NURSE (PDRN) STATED THE WRONG THERAPY PROGRAM WAS USED AND THE PATIENT WAS NOT CONNECTED WHEN THERAPY WAS IN INITIAL DRAIN. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE (PDRN) CONTACTED (B)(4) REQUESTING ASSISTANCE WITH REPRIMING ON THE HOMECHOICE (HC) UNIT DURING SET UP. THE PDRN STATED THAT THE INITIAL DRAIN STARTED AND HE DIDN'T HAVE THE PATIENT CONNECTED. THE PDRN STATED HE TRIED TO BYPASS TO GET BACK TO PRIME SO HE COULD REPRIME THE SET UP. THE TSR EXPLAINED THAT SINCE THE INITIAL DRAIN STARTED, THERE WAS A RISK OF CONTAMINATION OF UNSTERILE AIR INTO THE SET. THE TSR ASSISTED THE PDRN TO END THERAPY AND ALSO EXPLAINED THAT BYPASSING WOULD ADD CYCLES ONTO THERAPY. THE TSR ADVISED THE PDRN TO START OVER WITH NEW SUPPLIES AND REVIEW THE THERAPY SETTINGS BEFORE STARTING THERAPY AGAIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL 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