BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3202276 · Received June 24, 2013

    Report

    Report Number
    2016493-2013-00280
    Event Type
    Death
    Date Received
    June 24, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOGS RECEIVED ONLY, DEVICE RECEIPT PENDING. AN EVENT LOG REVIEW WAS PERFORMED; NO PROGRAMMING ISSUES WERE IDENTIFIED THAT WOULD EXPLAIN WHY THE DOSE COMPLETED EARLY. DEVICE WERE REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS ZOSYN 100ML WAS TO BE INFUSED OVER 4 HOURS, BUT THE COMPLETE DOSE WAS INFUSED IN 20 MINUTES. THE NURSE STATE THAT SHE PROGRAMMED IT FOR A "REGULAR INFUSION" AND NOT AND "EXTENDED INFUSION." FOUR PC UNITS AND 14 PUMP MODULES WERE IN USE AND THE CUSTOMER IS NOT SURE WHICH PUMP WAS INFUSING THE ZOSYN AND CANNOT MATCH THE DATE AND TIME THE EVENT WAS SUPPOSED TO HAVE HAPPENED. WITH THE LOGS FROM THE PUMP. THE CUSTOMER STATED THAT PT WENT TO SURGERY AND DIED LATER; HOWEVER, "THE CAUSE OF DEATH WAS MASSIVE RIGHT HEART FAILURE AND IN NO MEANS RELATE TO THE ZOSYN INFUSION." A SIMILAR EVENT OCCURRED ON THE SAME PUMP MODULE LATER IN THE DAY. SEE REPORT #2016493-2013-00286 FOR THE SECOND EVENT. NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284769 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ECMO, MFR UNK: SERIAL # UNK| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)