BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3943222 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23153
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE WITH NO PROBLEMS NOTED. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES ELECTRICAL AND FUNCTIONAL TESTING ON THE DEVICE. THE DEVICE PASSED ELECTRICAL RITE BUT FAILED FUNCTIONAL RITE FOR ALARMING SYSTEM ERROR (SE) 2046 AND A DISPLAY ISSUE. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE PASSED ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTING. A REVIEW OF THE EVENT HISTORY LOG WAS PERFORMED AND IDENTIFIED THE FOLLOWING ALARMS: LOW DRAIN VOLUME, CHECK PATIENT LINE, CHECK LINES AND BAGS, AND SE 2046. THE CAUSE OF THE SE 2046 WAS DETERMINED TO BE A POOR CONNECTION BETWEEN TWO INTERNAL COMPONENTS. ONE OF THE COMPONENTS WAS REWORKED TO SOLVE THE PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS YET TO BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICE (GTS) REGARDING AN UNKNOWN ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1 OF 5 WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE TSR ADVISED THE HP TO SWAP THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2014 THIS WRITER CONTACTED THE HOME PATIENT (HP) REGARDING THE UNKNOWN ALARM THAT OCCURRED ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) STATED THAT THEY DID NOT KNOW WHAT ALARM HAD OCCURRED. THE HOME PATIENT (HP) HAD RECEIVED THEIR NEW HOMECHOICE (HC) MACHINE. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422042 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR