BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3103474 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11903
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN OPEN CLAMP ON AN USED LINES IS A KNOWN CAUSE OF A SYSTEM ERROR 2240. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) AND SYSTEM ERROR 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4. THE HOME PATIENT (HP) STATED THAT THERE WAS A CLAMP OPEN ON AN UNUSED LINE AND IT WAS NOT CAPPED. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HP CYCLE THE POWER TO CLEAR THE ALARMS. THE HP WOULD COMPLETE THERAPY WITH MANUAL EXCHANGES. 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
    204163 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE