BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4163542 · Received September 25, 2014

    Report

    Report Number
    2016493-2014-00453
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    FOLLOWING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) IN THE ENDOSCOPY SUITE, A PATIENT WAS TRANSFERRED TO THE PACU COMPLEX (POST ANESTHESIA CARE UNIT) DUE TO LACK OF ICU (INTENSIVE CARE UNIT) BED. THE REPORT SUGGESTS THAT THE PATIENT HAD BEEN HYPOTENSIVE FOR A FEW HOURS WHEN THE CLINICIAN NOTED THAT SHE HAD BECOME BRACHYCARDIC (BRADYCARDIC). A CODE BLUE WAS ACTIVATED FOLLOWING A CARDIAC ARREST AND WHEN THE ICU PHYSICIAN ATTENDED THEY NOTED THAT THE INFUSION OF NORADRENALINE WAS BEING ADMINISTERED AT A LOWER RATE THAN EXPECTED. CPR WAS INITIATED, HOWEVER THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596857 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death ALARIS SYRINGE MODULE TUBING: MODEL /TUBING UNK| ALARIS SYRINGE MODULES: SN (B)(4)| ALARIS PC MODULE: SN (B)(4)| ALARIS PUMP MODULE TUBING: MODEL/TUBING UNK