BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850514 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03987
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE SYSTEM ERROR IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE TO THE HOME PATIENT REGARDING THE REPORT OF A SYSTEM ERROR 2240 ALARM. THE HOME PATIENT STATED SHE WENT TO THE CLINIC AFTER THIS INCIDENT AND THE NURSE CHANGED HER TRANSFER SET. NO PATIENT INJURY WAS REPORTED. THE HOME PATIENT HAS HAD NO FURTHER PROBLEMS AND IS CONTINUING THERAPY ON THE CYCLER AS USUAL. NO ADDITIONAL INFORMATION PROVIDED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS COMPLAINT. THE ROOT CAUSE OF THE SYSTEM ERROR 2240 ALARM WAS DUE TO THE HOME PATIENT DISCONNECTING FROM THE SET DURING THERAPY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE DURING DRAIN 3 OF 4. THE HOME PATIENT (HP) DISCONNECTED IN DWELL AND THOUGHT SHE CONNECTED BEFORE THE DRAIN STARTED, BUT WAS NOT SURE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL CALL.

    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 59 YR