BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 9955961 · Received April 13, 2020

    Report

    Report Number
    2016493-2020-00541
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    September 21, 2019
    Report Date
    March 29, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADMITTING DIAGNOSIS: NONISCHEMIC CARDIOMYOPATHY (NICM), ACUTE KIDNEY INJURY (AKI) ON CKD, SHOCK, AND ACUTE CHRONIC HEART FAILURE (CHF). PAST MEDICAL HISTORY: ALCOHOLIC CIRRHOSIS, PORTAL VEIN HYPERTENSION (HTN), HEPATITIS C (HCV), LIVER CANCER (HCC), DIABETES MELLITUS (DM), PULMONARY HTN, PANCYTOPENIA. ALTHOUGH REQUESTED, INFORMATION ON A1, A4, RACE AND ETHNICITY WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE, THE MODULE TURNED OFF WITHOUT ALARMING. THE EVENT OCCURRED AT THE INTENSIVE CARE UNIT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. PER NON-BD BIOMEDICAL ENGINEER, DEVICES WERE INSPECTED AND NO ISSUES WERE FOUND. RISK AUTHORIZATION CLEARED THEM FOR RELEASE AND ALL DEVICES WERE PLACED BACK IN SERVICE.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER DECLINED TO RETURN THE DEVICE FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. ADMITTING DIAGNOSIS: NICM, AKI ON CKD, SHOCK, AND ACUTE CHF. PAST MEDICAL HISTORY: ALCOHOLIC CIRRHOSIS, PORTAL VEIN HTN, HCV, HCC, DM, PULMONARY HTN, PANCYTOPENIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE, THE MODULE TURNED OFF WITHOUT ALARMING. THE EVENT OCCURRED AT THE INTENSIVE CARE UNIT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. PER NON-BD BIOMEDICAL ENGINEER, DEVICES WERE INSPECTED AND NO ISSUES WERE FOUND. RISK AUTHORIZATION CLEARED THEM FOR RELEASE AND ALL DEVICES WERE PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419062 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR PRI TUBING, 8015, THERAPY DATE (B)(6) 2019