BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2427865 · Received January 18, 2012

    Report

    Report Number
    2016493-2012-00065
    Event Type
    Death
    Date Received
    January 18, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 19, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER IS REQUESTING THE PUMP BE EVALUATED BECAUSE OF A PATIENT DEATH. THEY ARE NOT ALLEGING PUMP MALFUNCTION BUT DUE TO THE DEATH NEED THE PUMP TO BE EVALUATED AS PART OF THEIR INVESTIGATION INTO THE INCIDENT. THEY ARE LOOKING FOR EVENTS BETWEEN (B)(6), 2011. THE PATIENT HAD A NORMAL SALINE INFUSION AT 125ML/HOUR THAT WAS STARTED ON (B)(6), 2011 AT 1530 AND ON (B)(6), 2011 AT 1723 THE TOTAL INFUSED WAS 875ML. THE PATIENT HAD TWO DOSES OF ANCEF (CEFAZOLIN) 50ML, ONE AT 2000 ON (B)(6), 2011 AND ANOTHER AT 0130 ON (B)(6), 2011. PHENERGAN 5ML WAS GIVEN AT 0230 ON (B)(6), 2011. THE PATIENT WAS ON PCA MORPHINE ON A NON-CAREFUSION PUMP. THE CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT DETAILS ARE AVAILABLE. MANUFACTURER'S REPORT NUMBER: 2016493-2012-00065.

    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 65 YR Death THERAPY DATE (B)(6)| ALARIS ADMINISTRATION SET: MODEL/LOT UNKNOWN| ALARIS PC UNIT: SN (B)(4)| NON-CAREFUSION PCA PUMP: SN UNKNOWN