BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1915243 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06578
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HP STATED THAT THE ALARM OCCURRED BECAUSE SHE DISCONNECTED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO RECYCLE POWER TO CLEAR ALARMS. THE TSR FURTHER EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE HP TO PRESS STOP BEFORE DISCONNECTING TO AVOID THE ALARM. THE HP CONFIRMED SHE WOULD CALL HER NURSE REGARDING THE AIR DETECTION ALARM AND RECONNECTING. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT THE ALARM OCCURRED BECAUSE SHE DISCONNECTED. THE HP CONFIRMED SHE WAS AWARE OF THE PROPER PROCEDURES ON HOW TO PREVENT THE ALARM FROM OCCURRING. NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR