BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2192920 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00320
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICES HAVE BEEN RECEIVED AND AN INVESTIGATION IS COMPLETE OR FURTHER INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    NURSE REPORTS THAT A FULL BAG OF DOPAMINE WAS HUNG BUT SEVERAL HOURS LATER, THE NURSE NOTES THAT ALTHOUGH THE VTBI COUNTED DOWN AND THE VI INCREASED, THE BAG DID NOT INFUSE. THERE WAS NO ALARM DURING THE INFUSION. BIOMED EXAMINED THE PC UNIT LOGS AND SAW A LOT OF PROGRAMMING, ALARMS AND ALERTS. ALSO THE MODULE WAS MOVED AROUND SEVERAL TIMES, AT LEAST ONE TIME, IT WAS REMOVED WITHOUT BEING PAUSED OR TURNED OFF WHICH RESULTED IN A CHANNEL DISCONNECT ALARM. SHE ALSO SEES WHERE THE INFUSION WAS ORIGINALLY PROGRAMMED USING GUARDRAILS BUT AT SOME POINT THE USER CHANGED THE PROGRAMMING TO A BASIC INFUSION. BIOMED ALSO EXAMINED THE TUBING AND REPORTS THAT THE DISPOSABLE SET HAS TWO AREAS IN THE SILICONE TUBING THAT LOOK AS THOUGH THEY ARE COMPRESSED AND HAS A CHANNEL RUNNING DOWN ALONG THE COMPRESSED AREA. CUSTOMER STATES THAT NO ADDITIONAL 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 THERAPY DATE:| THERAPY DATE:| ALARIS PUMP MODULE: S/N (B)(4)| THERAPY DATE:| ALARIS PUMP MODULE: (B)(4)| THERAPY DATE:| ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS PC UNIT: S/N (B)(4)| MODEL AND LOT UNKNOWN