BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3092624 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11270
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 ALARM IS CONFIRMED AS THE HOME PATIENT STATED THEY DID NOT HAVE THE SUPPLY BAG CONNECTED ALL THE WAY AND IT BECAME DISCONNECTED. NOT PROPERLY CONNECTING THE BAGS IS A USE ERROR THAT CAN CAUSE THIS TYPE OF ALARM. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING 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. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) DURING DWELL 2 OF 4. THE HOME PATIENT (HP) STATED THEY DID NOT HAVE THE SUPPLY BAG CONNECTED ALL THE WAY AND IT BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE THE CASSETTE. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194839 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 HOME CHOICE