BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023270 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00128
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. PARTIAL EVENT LOGS AND THE DATA SET HAVE BEEN RECEIVED ALONG WITH A PHOTO OF THE IV SET UP. THE EVAL IS PENDING AND A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PHARMACIST REPORTED A SECONDARY BAG OF KCL 40 MEQ/250 ML WAS INFUSING AT 62.5 ML/HR, BUT WHEN THERE WAS STILL 40-50 ML LEFT IN THE BAG, THE RATE SWITCHED TO THE PRIMARY RATE OF 100 ML/HR. THE PT NOTED THAT HER IV INFUSION SITE WAS BURNING BUT THERE WAS NO LASTING HARM REPORTED. THE PRIMARY WAS 0.9NS SET TO INFUSE AT 100 ML/HR. THE PHARMACIST ALSO REPORTED THAT WHEN ADDING IV ADDITIVES, THEY HAVE A 10% RULE WITH THEIR IVPB PREPARATION. THIS BAG WAS ABOUT A TOTAL OF 260 ML AS THEIR POTASSIUM CHLORIDE CONCENTRATION IS 40 MEQ/250ML. SHE WAS NOT SURE WHEN THE SECONDARY WAS ACTUALLY HUNG, BUT STATED THAT BASED ON THE VOLUME REMAINING, IT HAD TO BE ABOUT 2-3 HOURS PRIOR AS THEY WERE INFUSING THE 10 MEQ/HR. THE PT BEGAN COMPLAINING OF HAND PAIN AROUND 1500 AND THAT WAS WHEN IT WAS NOTED THE POTASSIUM RIDER RATE WAS AT 100 ML/HR. MEDICAL INTERVENTION WAS NOT REQUIRED. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84757 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE:| ALARIS PUMP MODULES: SNS (B)(4)| MFR, MODEL, AND LOT NUMBER UNKNOWN| THERAPY DATE:| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE ADMINISTRATION SET:| MFR, MODEL, AND LOT NUMBER UNKNOWN| THERAPY DATE:| SECONDARY ADMINISTRATION SET: