BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1972873 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01199
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 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). 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF PATIENT DISCONNECTING A SUPPLY BAG AND RECONNECTING IT IN EFFORTS TO CLEAR A CHECK FINAL LINE ALARM COULD NOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK FINAL LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 4 OF 4. DURING TROUBLESHOOTING, THE HP REPORTED HE HAD DISCONNECTED THE SUPPLY BAG, RECONNECTED IT, THEN ENDED THERAPY. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP WHO REPORTED THAT THIS WAS THE ONLY OCCURRENCE OF THIS TYPE OF EVENT. HP HAD ALREADY SPOKEN TO HIS NURSE ABOUT THIS EVENT. THE HP IS AWARE OF PROPER PROCEDURE FOR THERAPY. HP STATED THAT THERE WERE NO INJURIES OR INFECTIONS NOTED AS A RESULT OF THE DISCONNECTION AND RE-CONNECTION.

    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 70 YR HOMECHOICE PERITONEAL DIALYSIS CYCLER