BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1980005 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01550
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 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). ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE NURSE WHO INDICATED THAT THEY REPLACED THE PATIENT'S TRANSFER SET AND PLACED HER ON PROPHYLACTIC ANTIBIOTICS. THE NURSE STATED THE PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A USER ERROR REPORT OF THE PATIENT DISCONNECTING AND NOT PLACING A FLEXICAP ON THE PATIENT LINE. PATIENT LINE SHOULD BE CAPPED WHEN DISCONNECTED. PATIENT RECONNECTED. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH CONTAMINATED PATIENT LINE THE WHILE USING THE HOMECHOICE (HC) DURING DWELL 2 OF 3. THE CAREGIVER EXPLAINED THE PATIENT DISCONNECTED AND DID NOT PUT A CAP ON THE PATIENT LINE. THE PATIENT THEN RECONNECTED. GTS ASSISTED THE CAREGIVER WITH ENDING THERAPY AND ADVISED THEM TO USE A MANUAL BAG AND CONTACT THE PATIENT'S DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 84 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)