BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880669 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04853
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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). A SAMPLE WAS NOT AVAILABLE FOR EVALUATION.A FOLLOW UP MEDWATCH REPORT WILL BE SUBNITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE CHECK PATIENT LINE ALARM WAS UNDETERMINED. HOWEVER, A LABELING REVIEW WAS COMPLETED AND FOUND TO BE ADEQUATE FOR THE USE ERROR RELATED TO THE PATIENT DROPPING THE PATIENT LINE ON THE FLOOR. THE REPORTED ISSUE WAS RESOLVED OVER THE PHONE. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 6 OF 7. THE HOME PATIENT (HP) DISCONNECTED TO USE THE RESTROOM AND DROPPED THE LINE ON THE FLOOR. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP END THERAPY. THE HP STATED HE WOULD CONTACT HIS NURSE REGARDING MISSED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL CALL. THE PROBLEM WAS RESOLVED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR