BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4230482 · Received October 22, 2014

    Report

    Report Number
    2016493-2014-00504
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF FENTANYL STATING THAT A 100 ML BAG WHICH SHOULD HAVE LASTED 5 HOURS WAS FOUND EMPTY AFTER APPROXIMATELY AN HOUR AND A HALF. THE PREVIOUS BAG HAD INFUSED OVER 5 HOURS AS EXPECTED. AT 2129, THE NURSE HUNG A NEW 100 ML BAG (CONCENTRATION 10 MCG/ML) USING THE SAME TUBING, VERIFIED THE EXISTING RATE OF 20 ML/HR, AND CHANGED THE VTBI TO 90 ML; NO OTHER PROGRAMMING CHANGES WERE MADE. SHE CHECKED THE PATIENT AT AROUND 2255 AND FOUND THE DRIP CHAMBER AND ENTIRE BAG WERE EMPTY. THE DEVICE HAD NOT ALARMED. THERE WAS NO CLINICAL EFFECT ON THE PATIENT, WHO HAD PREVIOUSLY BEEN INTUBATED AND PLACED ON THE VENTILATOR DUE TO HIS ADMITTING DIAGNOSIS. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674363 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR IV BAG OF 0.9% SODIUM CHLORIDE INJECTION USP| ALARIS PCU SN: (B)(4)| IV BAG FENTANYL, MANUFACTURER/LOT/EXPIRATION: UNK| MODEL 2420-0007, LOT: UNK| ALARIS PUMP MODULE ADMINISTRATION SET,| ALARIS PUMP MODULE, SN: (B)(4)| ALARIS PUMP MODULE, SN: (B)(4)| ALARIS PUMP MODULE, SN: (B)(4)| LOT: P319814, EXP. 12/01/2015, MANUFACTURER: UNK| VENTILATOR, MFR/MODEL/SERIAL NUMBER: UNK