BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3082990 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10672
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION (UF) REMOVAL SET TOO LOW. THE DEVICE WAS SENT FOR SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN 105 ALARM ON A HOMECHOICE (HC) DEVICE AFTER USE. THE HOME PATIENT (HP) STATED THE REGISTERED NURSE (RN) HAD HER DO A MANUAL DRAIN AND SHE DRAINED OUT 600ML, AND THE LAST FILL VOLUME (LFV) IS 500ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE THERAPY SETTING, THERAPY LOG, AND ULTRAFILTRATION (UF) PER CYCLE. THE TSR ASKED THE HP THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) TROUBLESHOOTING QUESTIONS. THE HP STATED SHE IS DOING A MANUAL BAG WITH ANTIBIOTICS DURING THE DAY BECAUSE SHE HAS PERITONITIS. THE TSR EXPLAINED THE HC WILL BE SWAPPED OUT AND RECOMMENDED THE HP TAKE THE PROCARD OUT. THE TSR ADVISED THE HP TO CONTACT THE RN ABOUT THE SWAP, AND THE INITIAL DRAIN ALARM SETTING AT 0ML. THE TSR EXPLAINED HOW TO DO A MANUAL DRAIN IF THE HP DOES NOT DRAIN COMPLETELY IN THE INITIAL DRAIN (IDRAIN), AND RECOMMENDED THE HP REVIEW THE DRAIN VOLUME (DV) WHILE SHE IS DRAINING. THE 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. THERAPY IS TIDAL, TOTAL VOLUME (TV) IS 8000ML, TOTAL TIME (TT) IS 9:00, FILL VOLUME (FV) IS 1700ML, TIDAL VOLUME IS 85%, TOTAL UF (TUF) IS 150ML, LAST FILL VOLUME (LFV) IS 500ML, DEXTROSE IS SAME, WEIGHT UNITS POUNDS (LB), PATIENT WEIGHT IS (B)(6), CYCLE %, DWELL 1:28, TIDAL VOLUME 1445, UF PER CYCLE IS 30, AUTO DIM IS NO, IDA IS 0ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184105 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE