BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2111958 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07021
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. LABELING REVIEW FINDS THE LABELING ADEQUATE FOR THE USER ERROR IDENTIFIED IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY (B)(6) 2011, THE HOMECHOICE (HC) MACHINE SOUNDED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING DWELL 4 OF 4 . THE PATIENT DISCONNECTED SOME TIME PRIOR TO THE ALARM AND RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) THAT AIR HAS ENTERED THE SETUP. THE HP RECYCLED POWER AND THE TSR ADVISED THE HP THERAPY HAD ENDED AND WILL NEED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. TSR EXPLAINED DISCONNECTING PROCEDURES TO HP. THE HP STATED HE DID NOT HAVE MANUAL SUPPLIES SO WILL CALL THE HOSPITAL FOR FURTHER INSTRUCTIONS. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE