BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PCA MODULE

    MDR report key: 4340028 · Received December 10, 2014

    Report

    Report Number
    2016493-2014-00548
    Event Type
    Death
    Date Received
    December 10, 2014
    Report Date
    November 11, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER'S REPORT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED CAREFUSION FOR ASSISTANCE BECAUSE THE PHYSICIAN WAS UNABLE TO ADMINISTER A BOLUS OF FENTANYL VIA THE PCA MODULE. THE PT WAS RECEIVING FENTANYL 400 MCG/HR AND THE PHYSICIAN WANTED TO ADMINISTER A 400 MCG BOLUS EVERY 20 MINUTES. THE DEVICE DISPLAYED THE MAX DOSE AND WOUND NOT ALLOW THE BOLUS TO BE ADMINISTERED. THE CUSTOMER STATED THAT THE PT "PASSED AWAY". THE CUSTOMER DECLINED AN EVENT LOG REVIEW OR DEVICE EVAL BY CAREFUSION, AND DID NOT ALLEGE OR ATTRIBUTE ANY DEVICE MALFUNCTION TO THE PT'S DEMISE. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797126 ALARIS PCA MODULE PUMP, INFUSION FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARI PC UNIT: SN UNK| PCA INFUSION SET: MFR/MODEL/LOT UNK| PCA SYRINGE: MFR/MODEL/LOT UNK