BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2040143 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04115
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 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). THIS COMPLAINT FOR CHECK YOUR POSITION ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. RENAL QUALITY ENGINEERING AND THE MANUFACTURING SITE WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL FURTHER TAKE CORRECTIVE AND PREVENTIVE ACTION(S), AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A CHECK YOUR POSITION ALARM WHILE USING THE HOMECHOICE (HC) DURING FILL 1. (B)(4) HAD THE PATIENT CLOSE/OPEN THE TRANSFER SET THREE TIMES, MOVE THE CLAMP AND RUB THE LINE, PULL UP ON THE LINES, AND CHECK THE LINES FOR FIBRIN OR AIR. THE PATIENT STATED THERE WERE LARGE AIR BUBBLES IN THE PATIENT LINE. (B)(4) ADVISED THE PATIENT TO END THERAPY AND START OVER WITH NEW SUPPLIES. (B)(4) THEN WALKED THE PATIENT THROUGH ENDING THERAPY. THE PATIENT ELECTED TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THEY WERE ABLE TO CONTINUE THERAPY WITH A NEW CASSETTE. THE PATIENT DID NOT NOTICE ANY DEFECTS WITH THE ORIGINAL CASSETTE. THE SAMPLE WAS DISCARDED, BUT THE PATIENT WAS ABLE TO RETAIN THE LOT INFORMATION. THE PATIENT FURTHER STATED SHE CONTACTED HER DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10K18073

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE