BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 9546733 · Received January 3, 2020

    Report

    Report Number
    2016493-2020-00052
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    November 15, 2019
    Report Date
    December 13, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT A HEPARIN INFUSION HAD OVER INFUSED COULD NOT BE CONFIRMED OR DUPLICATED. THE LOG ANALYSIS DID CONFIRM A HEPARIN INFUSION HAD BEEN MANUALLY TERMINATED EARLY ON THE DATE OF (B)(6) 2019; HOWEVER THE CAUSE FOR ITS EARLY TERMINATION COULD NOT BE ASCERTAINED FROM THE LOG. TESTING OF THE PUMP MODULE FOUND IT TO BE INFUSING WITHIN SPECIFICATION WITHOUT ANY OBSERVATIONS OF UNREGULATED FLOW OCCURRING. THE PUMP MODULE¿S PLATEN ASSEMBLY WAS FOUND TO BE MISSING ITS UPPER SPRING BUTTON CAP AND SPRING; HOWEVER, THIS WAS DETERMINED TO NOT BE A CONTRIBUTING FACTOR FOR THE REPORTED INFUSION EXPERIENCE. A ROOT CAUSE FOR THE REPORTED HEPARIN OVER INFUSION COULD NOT BE DEFINITIVELY IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE MEDICAL INTERMEDIATE CARE UNIT THAT THE PATIENT WAS EXPERIENCING A NSTEMI. DURING A HEPARIN INFUSION, THE SYSTEM OVER INFUSED WHICH LEAD TO THE ADMINISTRATION OF VITAMIN K TO THE PATIENT. THERE WAS NO LASTING EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS 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

    IT WAS REPORTED FROM THE MEDICAL INTERMEDIATE CARE UNIT THAT THE PATIENT WAS EXPERIENCING A NSTEMI. DURING A HEPARIN INFUSION, THE SYSTEM OVER INFUSED WHICH LEAD TO THE ADMINISTRATION OF VITAMIN K TO THE PATIENT. THERE WAS NO LASTING EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9312 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 8100, THERAPY DATE (B)(6) 2019.| PRI TUBING, 8015, THERAPY DATE UNKNOWN