BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990491 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05334
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE. THE PATIENTS ARE INSTRUCTED TO DISCARD THE DISPOSABLE SET AND ALL SOLUTION BAGS AT THE END OF THERAPY. POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. BAXTER TRAINING MANUAL AND LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERRORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD REUSED A SINGLE USE PRODUCT DURING PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS NOT CONNECTED TO THE HOMECHOICE (HC). THE HP STATED THAT HE HAD THE CASSETTE OUT, BUT COULD NOT FIND WHERE THE DRAIN LINE DISCONNECTS FROM THE CASSETTE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THAT THE DRAIN LINE STAYS ON THE CASSETTE. THE TSR ASKED IF THE HP USES A DRAIN LINE EXTENSION AND THE HP STATED THAT HE THINKS SO. THE TSR ASKED IF THERE IS A WHITE SPIKE THAT CONNECTS A DRAIN LINE WITH AN EXTRA LINE, AND THE HP STATED YES. THE TSR EXPLAINED THAT THE HP NEEDS TO PUT A NEW CASSETTE AND NEW DRAIN LINE EXTENSION ON EVERY NIGHT. THE HP STATED THAT HE THINKS THE NURSE HAS BEEN USING THE SAME CASSETTE AND DRAIN LINE EVERY NIGHT. THE TSR SUGGESTED THE HP CONTACT THE COMPANY THAT HIRED THE NURSE AND LET THEM KNOW. THE HP IS GOING TO SETUP THE MACHINE WITH ALL NEW SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS 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
    93930 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE