BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2091460 · Received May 4, 2011

    Report

    Report Number
    2016493-2011-00300
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE: 05/04/2011. (B)(4). LOG REVIEW PENDING. THE LOGS FOR THE REQUESTED LOG REVIEW HAVE BEEN RECEIVED, BUT HAVE NOT YET BEEN REVIEWED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE AN EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF CHANNEL ERROR CAUSING THE PCU PANEL TO UNLOCK AND AN UNDER INFUSION OF LEVOPHED. DURING TRANSPORT TO OPERATING ROOM, NURSE NOTED A CHANNEL ERROR. ON ARRIVAL IN OPERATING ROOM HOLDING, IT WAS NOTED THAT THE LEVOPHED INFUSION WAS PAUSED. THE PATIENT WAS FOUND TO BE HYPOTENSIVE AND THE CHANNEL WAS RESTARTED. POST-OP, IT WAS NOTED THAT THE PUMP STILL SHOWED "CHANNEL ERROR" AND THAT THE FRONT OF THE PCU INDICATED THE PUMP PANEL, AND THEREFORE, THE PUMPS WERE UNLOCKED, WHICH WAS NOT EXPECTED. STAFF TOOK OUT THE MODULE SHOWING CHANNEL ERROR AND RE-SITUATED THE OTHER PUMP MODULES. THE PUMPS THEN LOCKED AND SHOWED "LOCKED PANEL" ON THE FRONT OF THE PCU, REQUIRING CLINICIAN ID BADGE TO UNLOCK THE PUMP AS EXPECTED. PATIENT WAS UNSTABLE PRIOR TO TRANSPORT TO OPERATING ROOM, BUT RETURNED FROM OPERATING ROOM IN STABLE CONDITION WITH NO LASTING EFFECT FROM THE LEVOPHED BEING OFF UNEXPECTEDLY. THEIR DATA SET REQUIRES CLINICIANS TO USE AUTO-ID OR TO RELEASE TAMPER SWITCH FOR ALL PROGRAMMING. REPORTER DOES NOT KNOW WHICH CHANNEL HAD THE CHANNEL ERROR OR WHICH CHANNEL WAS SET UP FOR LEVOPHED. REPORTER AND BIOMED WERE INFORMED THAT IN AUTHORIZED USER MODE (CLINICIAN ID REQUIRED), THE SYSTEM EXITS TAMPER RESIST MODE WHEN A CHANNEL ERROR, SYSTEM ERROR, OR DISCHARGED BATTERY (LB3) SCREEN IS DISPLAYED. THE REPORTER AND BIOMED STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ALARIS PC UNIT: S/N (B)(4)