BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022660 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03323
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP WITH HOME PATIENT THE (HP) REGARDING THE USE ERROR, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT SHE CHANGES OUT ALL THE SUPPLIES NOW. PER HP, HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. QUALITY ENGINEERING SUMMARY: THIS COMPLAINT FOR A REPORT OF A USER ERROR WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(6) FOR ASSISTANCE. THE HOME PATIENT (HP) STILL HAS THE SET UP ON THE HC MACHINE. THE HP RESTARTED THE PRIMING AND THE ALARM REPEATED. THE HP REVEALED THAT SHE ONLY CHANGED THE SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT THE COMPLETE SET UP NEEDED TO BE CHANGED, BUT THE HP ONLY WANTED TO CHANGE ONE BAG AT A TIME. THE TSR ADVISED IF SHE DID THAT AND IT GOT TO CONNECT, SHE WOULD HAVE TO RESTART WITH ALL NEW SET UP. THE HP HAD DECIDED TO CHANGE THE COMPLETE SET UP AND THE HC WAS PRIMING FINE. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PD CYCLER