BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2801468 · Received October 11, 2012

    Report

    Report Number
    9616066-2012-00717
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    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 THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN RN ON THE TELEMETRY FLOOR WAS GIVING A SECONDARY INFUSION OF POTASSIUM 40 MILLIEQUIVALENTS IN 220 ML INFUSION OVER 6 HRS AT RATE OF 37ML/HR AND NOTICED THAT THE BAG EMPTIED PREMATURELY, IN 1 1/2 - 2 1/2 HRS. BAG WAS HUNG AT 8:48 AM ON (B)(6) 2012. NO ALARMS WERE OBSERVED. RN FOUND THE SECONDARY BAG EMPTY WITH PRIMARY BAG (LACTATED RINGERS SOLUTION) DRIPPING. THE RISK MANAGER THINKS THAT THE SECONDARY RAN INTO THE PRIMARY BAG, AS IT WAS SLIGHTLY MORE FULL. ADDITIONAL POTASSIUM LEVELS WERE DRAWN AS A RESULT OF EVENT. THE PT WAS MONITORED FOR ADVERSE EVENTS; NO SIGNIFICANT SPIKES IN SERUM POTASSIUM, CHANGES IN TELEMETRY, OR BURNING AT IV SITE WERE REPORTED. RNS AND BIOMED TESTED THE AFFECTED SET AND PUMP TO ATTEMPT TO DETERMINE FAILURE MODE PRIOR TO CALLING CAREFUSION. THEY FOUND THAT THE SECONDARY FLUID BACKED UP INTO THE PRIMARY BAG. THE PUMP TESTED WITHIN SPECIFICATION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT: SN UNK| LOT UNK| ALARIS SECONDARY ADMINISTRATION SET: MODEL 72213N,| ALARIS PUMP MODULE: SN UNK