BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2882589 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07895
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AIR IN TUBING (WITHOUT ALARM) DUE TO USE ERROR WAS CONFIRMED BECAUSE THE HOME PATIENT (HP) STATED THEY WENT TO CONNECT TO THE HOMECHOICE AND ACCIDENTLY FLUNG THE END OF THE LINE WHEN REMOVING THE CAP. THIS RESULTED IN A HALF INCH AIR GAP IN THE PATIENT LINE, WHICH WAS EXPOSED TO AIR FOR A FEW MINUTES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER AS THE SUPPLIES CURRENTLY CONNECTED WERE COMPROMISED. HOWEVER, SINCE IT CANNOT BE DETERMINED WHY THE HOME PATIENT (HP) ACCIDENTLY FLUNG THE END OF THE LINE WHEN REMOVING THE CAP, THE AS DETERMINED CAUSE FOR THIS COMPLAINT IS USE ERROR. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THE HOME PATIENT (HP) WENT TO CONNECT AND ACCIDENTLY FLUNG THE END OF THE LINE, WHEN REMOVING THE CAP DURING THERAPY ON THE HOME CHOICE (HC), AND NOW THERE WAS A HALF INCH GAP OF AIR IN THE LINE. THE HP STATED THE TIP OF THE LINE HAD BEEN EXPOSED TO AIR FOR A FEW MINUTES AND WANTED TO KNOW IF SHE SHOULD START OVER WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER AS THE SUPPLIES CURRENTLY CONNECTED WERE COMPROMISED. THE TSR HAD THE HP CYCLE THE POWER TO GET BACK TO PRESS GO TO START. THE HP UNDERSTOOD THE EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE