BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3010931 · Received March 14, 2013

    Report

    Report Number
    2016493-2013-00137
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES WERE RETURNED FOR THIS INVESTIGATION. THE REPORTED COMPLAINT OF AN OVERINFUSION OF LIPIDS COULD NOT BE CONFIRMED. A REVIEW OF THE PCU EVENT LOG FOR THE LIPIDS (FAT EMULSION 20%) INFUSION FOUND THAT THE INFUSION WAS INITIALLY PROGRAMMED AT 9:19 PM ON (B)(6) 2013 TO INFUSE AT A FLOW RATE CALCULATED AT 5.3 ML/HR FOR DURATION OF 24 HOURS. OVER THE NEXT 24 HOURS, THE INFUSION WAS STOPPED AND RESTARTED SEVERAL TIMES UNTIL 9:35 PM ON (B)(6) 2013 WHEN IT ENDED. TOTAL VOLUME INFUSED DURING THE 24 HOUR TIME PERIOD WAS CALCULATED AT 103.2 MLS. NO PROGRAMMING EVENTS WERE FOUND 3 1/2 HOURS PRIOR TO THE INFUSION BEING STOPPED. THIS WOULD SUGGEST THAT THE INFUSION WAS NOT PROGRAMMED AT THAT TIME AS REPORTED BY THE CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT DETERMINED THROUGH THE LOG REVIEW. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN INFUSION OF LIPIDS WENT IN OVER 3.5 HOURS INSTEAD OF 24 HOURS. TPN AND LIPIDS WERE ADMINISTERED SIMULTANEOUSLY, BOTH AS PRIMARY INFUSIONS CONNECTED AT A Y-SITE TO INFUSE VIA A CENTRAL LINE. ON (B)(6) 2013, THE NURSE PROGRAMMED THE LIPID INFUSION (FAT EMULSION 20%) TO INFUSE OVER 24 HOURS AT 5.3 CC PER HOUR. THIS SETTING WAS REPORTED TO HAVE BEEN CHECKED BY A SECOND NURSE AND TO BE CORRECT. THREE AND A HALF HOURS LATER, AT 2158, THE NURSES NOTICED THAT THE ENTIRE INFUSION OF LIPIDS HAD COMPLETED. THE PATIENT EXPERIENCED MODERATE TACHYCARDIA THAT LASTED APPROXIMATELY 3 HOURS. THE PATIENT'S M.D. WAS NOTIFIED AND HE ORDERED BLOOD DRAWS WITH REPORTEDLY NORMAL RESULTS. THE PATIENT RECOVERED WITHOUT COMPLICATIONS. CUSTOMER STATED THAT NO ADDITIONAL PATIENT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108389 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT: SN (B)(4)| ALARIS SYRINGE MODULE: MODEL 8100, SN (B)(4)| ALARIS PUMP MODULE: MODEL 8100, SN (B)(4)| LOT UNK| ALARIS PUMP MODULE ADMIN SET: MODEL 2420-0500