BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3070317 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09954
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED BY REVIEW OF THE LOGS. THE CAUSE WAS FOUND TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. THE DEVICE PASSED ALL FUNCTIONAL TESTING DURING EVALUATION AND WAS SENT FOR SERVICE. 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. H6 ADDITIONAL METHOD CODE ? 3372.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN OVERFILL SITUATION ON A HOMECHOICE (HC) DEVICE. THE HOME PATIENT (HP) TOLD THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) THAT HE HAD FELT OVERFILLED AND HAD ABDOMINAL PAIN. THE HP SAID THE HC FILLED WITH THE PRESCRIBED FILL VOLUME (FV) OF 3000ML IN FILL 2 OF 5. THEN THE HP STATED THAT THE HC ONLY DRAINED 300ML AND MOVED TO THE NEXT FILL. THE HP REPORTED HAVING PAIN IN FILL 3 OF 5 AND BYPASSED TO DRAIN BEFORE ENDING THERAPY EARLY. THE HP REPORTED HAVING NO ALARMS. THE PDRN DOES NOT HAVE ACCESS TO THE HC AND THE HP IS AT THE CLINIC. THE HP WAS NOT CONNECTED AND DID NOT HAVE SYMPTOMS AT THE TIME OF THE CALL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE 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. EVIDENCE OF A HIGH DRAIN ALARM WAS FOUND IN THE EVENT HISTORY LOG REVIEW DURING EVALUATION OF THIS DEVICE, WHICH COINCIDES WITH THE DATE OF THE REPORTED OVERFILL. THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, AND MEETS CRITERIA FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171882 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE