BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3120567 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12922
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. PER "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE", 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 REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD THE DEVICE OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) DEVICE ALARMED WITH SYSTEM ERROR (SE) 2240 DURING THE INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE HP HAD LEFT AN UNUSED LINE CLAMP OPEN. THE HP CLOSED THE CLAMPS AND CYCLED THE POWER TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO DISCARD SUPPLIES AND START OVER WITH NEW. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222766 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR HOMECHOICE