BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3031421 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08136
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING THERAPY QUESTIONS, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT HE CUTS HIS DRAIN LINE EVERY NIGHT WHEN SETTING UP THE HC'S SUPPLIES BECAUSE THE DRAIN LINE WAS TOO LONG FOR HIS PERSONAL HOME SETUP. THE HP STATED THAT HE HAD ACCIDENTALLY CUT HIS PATIENT LINE INSTEAD OF HIS DRAIN LINE. THE HP HAD NOT YET CONNECTED. THE HP HAD SOLUTION BAGS CONNECTED TO THE SUPPLY LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. 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
    134601 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE