BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2071246 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05101
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED AS THE PRODUCT CODE IS UNKNOWN. THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT LINE INADVERTENTLY SEPARATED FROM TRANSFER SET. THE CARE GIVER (CG) NOTICED THAT THE PATIENT LINE HAD BECOME UNSCREWED FROM THE TRANSFER SET. 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

    A CAREGIVER (CG) REPORTED TO BAXTER AFTER HOURS A SYSTEM ERROR (SE) 2240 ALARM (AIR IN SET) THAT OCCURRED ON A HOMECHOICE MACHINE DURING DWELL 6 OF 7. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE ALARM. THE CG STATED AT THE TIME OF THE CALL, THE PATIENT HAD ALREADY DISCONNECTED AND CYCLED POWER TWICE TO CLEAR ALARMS. THE CG FURTHER STATED THAT HE/SHE NOTICED THAT THE PATIENT LINE HAD BECOME UNSCREWED FROM THE TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SE 2240 INDICATES AIR ENTERED THE SET UP. THE CG ENDED THERAPY AND CONFIRMED TO INFORM THE NURSE OF THE INCIDENT. NO CLINICAL CONSEQUENCES OR MEDICAL INTERVENTION FOR THE PATIENT WAS REPORTED.

    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