BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1943177 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07463
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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 WAS NOT CONFIRMED AND NO ROOT CAUSE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE NO LOT NUMBER IS AVAILABLE. 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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LEAK IN THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THERE WAS NO ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO END THE THERAPY AND INFORMED THEM TO START OVER USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THIS REPORTED PROBLEM. DURING A FOLLOW UP CALL TO THE HP, THE HP'S CAREGIVER (CG) ANSWERED, AND SHE EXPLAINED THAT THE LEAK OCCURRED IN THE PATIENT LINE TUBING. THE CG STATED, THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT THE TIME OR PRIOR TO USING THEM. SHE STATED THAT THE HP NOTIFIED HIS NURSE AND STARTED OVER WITH A NEW ONE. PER THE CG, THE LEAK WAS NOT A RECURRING ISSUE AND IT OCCURRED ONLY THE ONE TIME. THE CG STATED, THE HP IS RESUMING WITH THERAPY AS USUAL. 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 64 YR HC CYCLER