BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3944754 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23301
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT USE ASEPTIC TECHNIQUE WHILE RECONNECTING. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INSTRUCTS THE USER TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS TO REDUCE THE CHANCE OF INFECTION. IT WARNS THE USER TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY THE DIALYSIS CENTER WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT USE ASEPTIC TECHNIQUE WHEN RECONNECTING TO A HOMECHOICE MACHINE FOR PERITONEAL DIALYSIS THERAPY. THE PATIENT DISCONNECTED FROM THERAPY TO GO TO THE BATHROOM. UPON RETURNING, THE PATIENT CONNECTED THEIR PATIENT LINE EXTENSION SET TO THE SETUP, RECONNECTED THEMSELVES TO THE LINE, AND THEN ATTEMPTED TO REPRIME THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT WITH ENDING THERAPY. PROPER PROCEDURES WERE REVIEWED AND THE PATIENT WAS ADVISED TO CONTACT THEIR NURSE REGARDING THE EVENT. WHILE THERE WAS PATIENT INVOLVEMENT, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422737 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE