BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1810468 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02770
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 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). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW-UP WITH THE REGISTERED NURSE (RN), THE RN STATED THE PATIENT DISCONNECTED AS SOON AS SHE SAW THE AIR IN THE LINE, CALLED BAXTER FOR ASSISTANCE, AND STARTED OVER WITH NEW SUPPLIES. THE RN SAID THE PATIENT DID NOT KNOW WHAT CAUSED THE AIR IN THE LINE. THE PATIENT DID NOT HAVE AN INJURY OR NEED MEDICAL ATTENTION DUE TO THE INCIDENT. THE RN STATED THAT THE PATIENT CONTINUED THERAPY USING THE HOMECHOICE. NO SAMPLE WAS KEPT BY THE PATIENT AND THE LOT NUMBER WAS UNKNOWN. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE RE-PRIMING ON THE HOMECHOICE MACHINE DURING FILL 1 OF 4 (AT BYPASS). THE HOME PATIENT (HP) DISCONNECTED BECAUSE THERE WERE A FEW AIR BUBBLES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ENDED THERAPY AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    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 54 YR