BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1901307 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05877
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 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). 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AIR IN THE PATIENT LINE. THE PATIENT HAD NOT OPENED THE PATIENT LINE CLAMP DURING PRIME AND THEN CONNECTED. AIR IN THE PATIENT LINE WAS NOTICED DURING INITIAL DRAIN. 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. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. 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 TECHNICAL SERVICE CENTER WHO NOTICED AIR IN THE PATIENT LINE DURING FILL 1 ON THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) STATED THAT SHE ACCIDENTLY LEFT THE PATIENT LINE CLAMP CLOSED DURING THE PRIME, BUT DID NOT CHECK THE LINE BEFORE CONNECTING. THE HP STARTED THERAPY AND THEN NOTICED THAT THE AIR WAS IN THE LINE. THE HP THEN STOPPED THERAPY AND CALLED BAXTER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT HP WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR THEN WALKED HP THROUGH ENDING THERAPY EARLY PROCEDURE. THE HP UNDERSTOOD EXPLANATION, ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) MOTHER REGARDING CONNECTING TO THE HOMECHOICE AFTER THE PATIENT LINE CLAMP BEING CLOSED DURING PRIME. THE HP'S MOTHER STATED THAT SHE USUALLY DOES THE THERAPY FOR THE HP BUT SHE WAS OUT AND THE HP DID IT HERSELF AND FORGOT TO OPEN THE CLAMP TO THE PATIENT LINE. THE HP REALIZED BEFORE SHE PUSHED THE BUTTON TO START THERAPY THAT SHE FORGOT TO OPEN THE CLAMP BUT CONNECTED AND SHOULDN'T HAVE. THE HP'S MOTHER STATED THAT HP STARTED OVER WITH NEW SUPPLIES.

    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