BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3983512 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25428
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG AS PERFORMED WITH A HIGH DRAIN ALARM NOTED. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED. A SIMULATED THERAPY, FULL RITE FUNCTIONAL TESTING, AND PNEUMATIC SYSTEM TESTING WAS PERFORMED. A SERVICE HISTORY REVIEW SHOWED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE CAUSE WAS DETERMINE TO BE A FALSE EMPTY AND THE INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE STATES IN THE WARNINGS: SETTING THE I-DRAIN ALARM VOLUME TOO LOW OR OFF CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN 105 ALARM OCCURRED DURING USE ON THE HOMECHOICE (HC). THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE NURSE STATED THE ISSUE WAS NOTICED WHEN CHANGING THE PATIENT FROM A LAST BAG FILL TO NO LAST BAG FILL. THE NURSE STATED THE INITIAL DRAIN WAS SET TO 0ML. THE NURSE STATED THE PATIENT DRAINED OUT 25ML FROM 2L. THE TOTAL ULTRAFILTRATION (UF) EQUALED 2750ML. THE THERAPY WAS SET TO TIDAL AND A FILL VOLUME (FV) EQUALED TO 2L. THE NURSE STATED THE INITIAL DRAIN ALARM EQUALED 1700ML PREVIOUSLY BUT THE PROGRAMMING WAS CHANGED WHEN THEY SWITCHED TO NO LAST BAG FILL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460113 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1