BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023250 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00125
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP MODULE HAS BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BIOMED CALLED TO REPORT THAT THE OCCLUSION ALARM FAILED TO WORK AS EXPECTED. HE REPORTED THAT A NURSE HAD STARTED AN INFUSION OF NITROGLYCERIN TO REDUCE PT'S BLOOD PRESSURE. IT WAS REPORTED THAT SHE DID NOT UNDO THE UPPER ROLLER CLAMP ON THE TUBING WHEN THE INFUSION WAS STARTED. AN HOUR INTO THE INFUSION, THE NURSE NOTICED THAT THE ROLLER CLAMP WAS STILL ON AND THAT NO MEDICATION HAD INFUSED. THE REPORTER STATED THAT THE NURSE EXPECTED THE OCCLUSION ALARM TO SOUND WHEN THE ROLLER CLAMP WAS LEFT ON. THE NURSE GOT A NEW DEVICE AND STARTED THE INFUSION ON THE PT WITHOUT PROBLEMS. THE PT RECEIVED EXTRA MONITORING DURING THE START OF THE NEW INFUSION BUT NO PT HARM OCCURRED; NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85331 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SN (B)(4)| ALARIS PUMP MODULE ADMIN SET(S)| ALARIS PC UNIT, SN (B)(4)