BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3202288 · Received June 27, 2013

    Report

    Report Number
    2016493-2013-00292
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE AND THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NURSE ATTEMPTED TO MOVE A PUMP MODULE FROM THE LEFT SIDE OF PC UNIT TO RIGHT SIDE, AND ENCOUNTERED AN UNEXPECTED SCROLLING MESSAGE ON ONE MODULE. PER THE CUSTOMER REPORT, THREE CHANNELS WERE INFUSING: CHANNEL A AND B WERE TO THE LEFT OF THE PC UNIT; CHANNEL A HAD BLOOD RUNNING AT 150 ML/HR, CHANNEL B HAD LEVOPHED AT 5 MCG/MINUTE (RATE UNSPECIFIED). CHANNEL C, ON THE RIGHT SIDE OF THE PC UNIT, HAD AN UNSPECIFIED INFUSION. THE NURSE NOTED THAT CHANNEL A WAS LOOSE AT THE BOTTOM AND NOT LOCKED ON. SHE ATTEMPTED TO LOCK IT IN, BUT IT WOULD NOT SNAP BACK INTO PLACE. THE LATCH WAS REPORTED TO BE STUCK AND REPORTEDLY THE "RN HAD TO PICK AT IT WITH HER FINGERNAIL TO GET IT OUT." IT WAS REMOVED WHILE IT WAS STILL RUNNING, AND MOVED TO RIGHT SIDE OF CHANNEL C. THE NURSE EXPECTED TO SEE THE REMAINING LEFT SIDED DEVICE (LEVOPHED INFUSION) RUNNING AT 5 MCG, HOWEVER, THE POSITION B DEVICE INDICATED BLOOD WAS RUNNING AT 150 ML/HR ON THE MESSAGE DISPLAY SCREEN. THE NURSE STOPPED THE LEVOPHED INFUSION AND TOOK THE DEVICE OUT OF SVC. THE PT EXPIRED SEVERAL DAYS AFTER REPORTED EVENT FOR REASONS NOT RELATED TO THIS EVENT; THE CUSTOMER IS NOT ALLEGING ANY PUMP INVOLVEMENT IN THE PT DEATH. CUSTOMER STATED THE USER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293042 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE ADMIN SETS: MODEL / LOT UNK| ALARIS PUMP MODULE: SN (B)(4)