BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120642 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07457
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 17, 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). THIS COMPLAINT FOR USE ERROR WAS CONFIRMED DUE TO THE PATIENT REPORTED REUSING THE SAME SUPPLIES FOR A NEW THERAPY. THE CAUSE OF THE USE ERROR IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR A REPORTED SYSTEM ERROR ALARM THAT OCCURRED ON (B)(6) 2011, THE CAREGIVER (CG) PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE HOME PATIENT (HP) DID NOT START OVER WITH NEW SUPPLIES THE NIGHT OF THE ALARM; RATHER, USED THE SAME SUPPLIES AND PERFORMED THE ENTIRE THERAPY WITH FOUR DWELLS. THE CG STATED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RESULTING FROM THIS EVENT.

    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 H11A31018

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE