BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2213579 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10777
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP PHONE CALL TO THE PATIENT REGARDING THE SAMPLE RETURN, IT WAS REVEALED THAT THEY DO NOT HAVE THE CASSETTE ANY LONGER; THE HP STATED THAT IT MAY HAVE BEEN USED-UP FOR ANOTHER THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) PROBLEM OF NEEDING ASSISTANCE ENDING THERAPY AS THERE WAS AIR IN LINE, THIS PROBLEM OCCURRED DURING USE. THE HP STATES HE WAS NOT CONNECTED TO THE HC. THE TSR ASSISTED THE HP WITH ENDING THE THERAPY AS REQUESTED. THE TSR INFORMED THE HP TO START OVER WITH ALL NEW SUPPLIES AND TO CONTACT THE RN. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE PATIENT ON (B)(4) 2011. THE PATIENT STATED THE FOLLOWING: NOTHING WAS SEEN THAT WOULD HAVE CAUSED THE AIR AND THE PATIENT THOUGHT IT MAY HAVE BEEN SOMETHING THEY DID BUT COULD NOT STATE WHAT SO A COMPANION SAMPLE WAS REQUESTED WITH LOT NUMBER H11E21028 AS THE ACTUAL SAMPLE WAS DISCARDED. NEW SUPPLIES WERE USED TO CLEAR THE AIR AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11E21028

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOME CHOICE