BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031950 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03746
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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). THIS COMPLAINT IS FOR A CHECK PATIENT LINE (CPL) ALARM AND WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE PATIENT, THERE WAS AIR IN THE PATIENT LINE. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. 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). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(6) REGARDING ASSISTANCE WITH A CHECK PATIENT LINE ALARM WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE DRAIN VOLUME WAS 8ML. (B)(6) HAD THE PATIENT PULL UP/DOWN ON THE LINES NEAR THE DOOR, CLOSE/OPEN THE TRANSFER SET, SLIDE THE PATIENT LINE CLAMP DOWN THE LINE, AND CHECK THE LINE FOR KINKS/FIBRIN/AIR. THE PATIENT STATED THERE WAS AIR IN THE LINE. (B)(6) ADVISED THE PATIENT TO START OVER WITH NEW SUPPLIES AND ASSISTED IN ENDING THERAPY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE PRO