BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1936717 · Received December 23, 2010

    Report

    Report Number
    1423500-2010-07199
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    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). THIS COMPLAINT IS FOR A REPORT OF A CONTAMINATED PATIENT LINE. THE CAREGIVER STATED THE PATIENT LINE WAS DROPPED AND NOW IT CONTAMINATED. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE RELATED USE ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING ASSISTANCE ON BYPASSING THE DAY EXCHANGE ON THE HOME CHOICE (HC) UNIT DURING USE, PATIENT NOT CONNECTED. THE CG STATED THE PATIENT LINE WAS DROPPED, AND NOW THAT IT'S CONTAMINATED, SHE WILL HAVE TO CALL THE NURSE TO HAVE THEM COME BACK OUT TO RESET THE HC BACK UP. THE CG WANTED TO KNOW IF THEY COULD BYPASS THE DAY EXCHANGE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SUGGESTED TO THE CG TO HAVE THE HC SET UP, CONNECT THE PATIENT, DO THE INITIAL DRAIN (I-DRAIN), LET THE HC MOVE TO FILL 1, AND THEN ONCE IT GOES TO DAY DWELL 1/1 TO ADVANCE IT TO DAY DRAIN 1/1. THE CG DOES NOT WANT TO SPEND THE 20 MINUTES IT TAKES TO DO THAT, SO THE TSR ADVISED HER TO CONNECT THE PATIENT, START THE I-DRAIN, THEN WHEN THE HC GOES TO DAY FILL 1/1 TO PRESS STOP AND CALL FOR BYPASS ASSISTANCE TO NIGHT FILL. PRODUCT SURVEILLANCE CONTACTED THE CG REGARDING THE REPORTED PROBLEM. THE HOME PATIENT (HP) HAD CONTINUED THERAPY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    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 74 YR PD CYCLER