BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2030122 · Received March 26, 2011

    Report

    Report Number
    1423500-2011-03724
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN, FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. LABELING WAS REVIEWED FOR RELATED USE ERROR(S) AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING DEVICE EVALUATION, AN ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE THERAPY LOGS: OCCURRENCE DATE (B)(6) 2011 AT 02:44, CYCLE 3, DRAIN VOLUME OF 3171 MILLILITERS (ML). ON 25 MAR 2011, PRODUCT SURVEILLANCE PROVIDED THE RESULTS OF EVALUATION TO THE WIFE OF THE HOME PATIENT. THE WIFE STATED THE PATIENT EXPERIENCED NO ADVERSE SYMPTOMS AND ADVISED SHE MONITORS THERAPY CLOSELY. THE WIFE STATED THE MINIMUM DRAIN PERCENTAGE WAS SET AT 75%. THE WIFE REPORTED NO ISSUE WITH THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR