BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2893171 · Received December 19, 2012

    Report

    Report Number
    2016493-2012-00520
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, LOGS/DEVICE HAVE NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE LOGS/DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PT WAS ON A MORPHINE PCA AND THE PT WAS FOUND UNRESPONSIVE. IN THE RUSH OF CARING FOR THE PT, AND THE HAND OFF FROM ONE UNIT TO ANOTHER, NO ONE SEEMS TO KNOW WHO CLEARED THE PCA AND SPO2 HISTORY AND THE DOCUMENTATION DOES NOT APPEAR TO MATCH THE PT CONDITION, AS IT HAS PT ADMINISTERING A DOSE WHEN SHE WAS LIKELY UNABLE TO DO SO. CUSTOMER WILL SEND DEVICE IN AND WANTS EVENT LOG REVIEW FOR PCA AND SPO2 FROM (B)(6) 2012 AT 1300 TO (B)(6) 2012 AROUND 0200, WHEN HISTORY WAS CLEARED. POST-OPERATIVELY, THE PT WAS ON MORPHINE PCA 2 MG/10 MINUTES ON DEMAND AND 2 MG BASAL RATE ON (B)(6) 2012 AT 1300 TO (B)(6) 2012 AROUND 0100. PT WAS FOUND UNRESPONSIVE AROUND 0100 ON (B)(6) 2012 AND CODED. PT WAS TRANSFERRED TO ICU AFTER THE CODE AND DIED ON (B)(6) 2012. THEY DO NOT BELIEVE THERE WAS ANY PCA MALFUNCTION THAT WOULD HAVE CONTRIBUTED TO THE DEATH. CUSTOMER REPORTED PT WAS ON OTHER ORAL PAIN MEDICATIONS THAT MAY HAVE LED TO THE UNRESPONSIVENESS. THERE IS NO CAUSE OF DEATH AT THIS TIME, PENDING AUTOPSY. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PCA ADMINISTRATION SET, MODEL/LOT UNK| ALARIS PUMP MODULE ADMIN SETS, MODEL/LOT # UNK| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PC UNIT, SN (B)(4)| ALARIS SPO2, SN (B)(4)