BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2132267 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07744
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A USE ERROR (FAILED TO FOLLOW PROPER THERAPY STEPS) WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS USE ERROR. THE NURSE STATED THAT SHE CHANGED OUT THE CASSETTE BUT REUSED THE SAME BAGS. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A REPORTED CHECK FINAL LINE ALARM THAT OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING PRIME, A NURSE (RN) STATED SHE HAD CHANGED THE CASSETTE; HOWEVER, DID NOT CHANGE THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SET UP WAS COMPROMISED SINCE THE ENTIRE SET UP WAS NOT CHANGED. THE PATIENT WAS NOT CONNECTED TO THE SET UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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