BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2071269 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05103
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED. REVIEW OF THE DEVICE?S HISTORY RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. BASED ON THE INFORMATION GATHERED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS USE ERROR. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER' TECHNICAL SERVICE CENTER REGARDING THERAPY QUESTIONS ON THE HOMECHOICE (HC) AFTER USE. THE HP STATED THE HC HAD MOVED THROUGH THE INITIAL DRAIN WITHOUT DRAINING HIM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) CHECKED THE HP' PROGRAM SETTING AND FOUND THAT THE HP HAD A LAST FILL EQUAL TO 2000 ML AND THE INITIAL DRAIN WAS SET FOR 0 ML. THE TSR INFORMED THE HP THAT WITH THE INITIAL DRAIN ALARM SET FOR 0 ML, IF THE UNIT DOES NOT GET A FLOW OF AT LEAST 50ML IN THE FIRST MINUTE IT WILL MOVE ON TO THE FILL. THE HP STATED HE WOULD NOTIFY THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) OF THE INFORMATION. ON (B)(6 2010,THE HP'S DIALYSIS FACILITY NOTIFIED BAXTER THAT THE HP WAS NO LONGER PERFORMING THERAPY ON THE HC. THE HP SWITCHED TO ANOTHER PRODUCT. NO FURTHER DETAIL WAS PROVIDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR