BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 3082661 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10659
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A SYSTEM ERROR 2240 DURING THE DWELL STAGE, WHERE THE HOME PATIENT WAS CONNECTED AND THE BLUE LINE CLAMP WAS OPEN. THIS COMPLAINT IS CONFIRMED BECAUSE LEAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE IS A USE ERROR THAT MAY CAUSE A SYSTEM ERROR 2240 AND CONTAMINATION. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING PERITONEAL DIALYSIS THERAPY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET) AND SE 2367, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 3. THE HOME PATIENT (HP) WAS CONNECTED AND THE BLUE LINE CLAMP WAS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECYCLED THE POWER CLEARED AND EXPLAINED ALARMS, THE HP DID NOT CLOSE CLAMP ON BLUE THE SUPPLY LINE, THE CALLER WOULD DISCARD SUPPLIES AND WILL USE MANUAL SUPPLIES TO CONTINUE THERAPY. THE HP WOULD CALL THE REGISTERED NURSE (RN) REGARDING THE AIR DETECT ALARM AND BEING CONNECTED. THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185098 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