BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2002941 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02521
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 5, 2011
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HOME PATIENT (HP) STATED HE HAD DISCONNECTED TO USE BATHROOM AND FORGOT TO PRESS STOP. THE HP STATED HE ALSO RECONNECTED TO MACHINE BEFORE THE ALARM OCCURRED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED BECAUSE THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A (B)(6) HOME PATIENT (HP) CONTACTED BAXTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DRAIN. THE HP STATED HE HAD DISCONNECTED TO USE THE BATHROOM AND FORGOT TO PRESS STOP. THE HP FURTHER STATED HE RECONNECTED BEFORE THE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM AND ADVISED THE HP TO DISCONNECT. THE HP CONFIRMED TO REMOVE THE CASSETTE. THE TSR EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE HP TO CONTACT HIS NURSE. THE HP CONFIRMED TO COMPLETE THERAPY WITH A MANUAL EXCHANGE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE