BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2073032 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05209
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. A REVIEW OF THE PREVIOUS SERVICE HISTORY RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THE INCIDENT. 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). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED HE SET UP THE HC, TOOK A SHOWER, THEN CAME BACK TO THE HC AND PRESSED GO. THE HC STARTED THE INITIAL DRAIN WITHOUT THE HP BEING CONNECTED. THE HP STATED HE FORGOT HE HAD ALREADY PRIMED THE HC. THE HP PRESSED STOP AND CONNECTED TO THE HC. THE HP PRESSED GO AND DID THE INITIAL DRAIN. THE HP THEN PRESSED STOP, DISCONNECTED AND RECONNECTED TO THE HC AND DID THE FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THAT THE SET-UP WAS POTENTIALLY COMPROMISED BECAUSE HE STARTED THE INITIAL DRAIN WITHOUT BEING CONNECTED. THE TSR ASSISTED THE HP WITH ENDING THERAPY. ON (B)(4) 2010, PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF POTENTIAL CONTAMINATION. THE PDN STATED THE HP DID NOT PERFORM THE INITIAL DRAIN. THE PDN STATED SHE DID NOT BELIEVE THE HP CONTAMINATED HIMSELF BUT CONNECTED TO THERAPY INCORRECTLY. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    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 79 YR