BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3971679 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24900
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THE HOME PATIENT (HP) REPORTED THAT A SUPPLY BAG FELL AND DISCONNECTED WHICH IS A KNOWN CAUSE OF THE ALARM. USE ERROR 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. IT INSTRUCTS THE USER TO PLACE SOLUTION BAGS ON A FLAT STABLE SURFACE. FURTHERMORE, IT WARNS THAT FALLING BAGS CAN RESULT IN A DISCONNECTION WHICH CAN LEAD TO CONTAMINATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON A HOMECHOICE (HC) DEVICE DURING DWELL 3 OF 5 OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. TROUBLESHOOTING REVEALED THAT THE SUPPLY BAG ON THE LAST FILL LINE FELL AND DISCONNECTED. A TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE HP. THE HP DID NOT WANT TO RESTART THERAPY AND PLANNED ON CONTACTING A REGISTERED NURSE (RN) REGARDING THE ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448141 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE