BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2242263 · Received September 10, 2011

    Report

    Report Number
    1423500-2011-12032
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED FOR USE ERROR - FAILED TO FOLLOW THERAPY STEPS. THE ROOT CAUSE WAS IDENTIFIED TO BE USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) HOME PATIENT (HP) HAD BYPASSED THE INITIAL DRAIN, FILL 1, DWELL 1, AND DRAIN 1. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) PRESS STOP AND DO A MANUAL DRAIN TOOK OUT 298ML AND THE MACHINE SAID STOP. THE HP SAID SHE HAS FLUID IN HER. THE TSR INFORMED THE HP TO USE MANUAL BAG AND CONTACT THE NURSE ASSISTED TO END THE THERAPY. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED HOME PATIENT (HP) ON (B)(4) 2011 REGARDING THE REPORTED ISSUE. THE HP REPORTED THAT SHE STOPPED USING THE CYCLER AND IS CURRENTLY ON HEMODIALYSIS. THE HP SAID THAT SHE WAS HAVING PROBLEMS WITH HER CATHETER, SHE COULD FILL BUT COULD NOT DRAIN. THE HP IS UNSURE WHEN SHE IS GOING TO GO BACK TO PD THERAPY. THE HP IS NOT RETURNING THE CYCLER. PER HP, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP?S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR