BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2743243 · Received September 13, 2012

    Report

    Report Number
    1423500-2012-17912
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN "ODD SMELL" EMANATING FROM THE DEVICE. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. THE EXTERNAL VISUAL INSPECTION WAS PERFORMED PER PAL1260005 AND REVEALED NO PROBLEMS. THE INTERNAL VISUAL INSPECTION REVEALED UNKNOWN CONTAMINATION ON THE BASE OF THE DEVICE. THE REPORTED ISSUE OF ODD SMELL WAS DETERMINED TO BE THE UNKNOWN OVERHEATED CONTAMINATION ON THE BASE OF THE DEVICE WITH THE ASSIGNABLE CAUSE OF CONTAMINATION. THE DEVICE DID NOT MEET SPECIFICATIONS DUE TO THE FINDING OF CONTAMINATION ON THE BASE OF THE DEVICE. THE DEVICE HAS BEEN IDENTIFIED TO BE SCRAPPED BASED ON THE CONTAMINATION FOUND DURING THE INSPECTION PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ODD SMELL LIKE BURNING CIGARETTES ON A HOMECHOICE (HC) MACHINE DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WILL SWAP FOR ODD SMELL IN BACK OF THE MACHINE. REGISTERED NURSE (RN) WILL PROGRAM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE HC MACHINE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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