BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 7208412 · Received January 19, 2018

    Report

    Report Number
    2016493-2018-00073
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 24, 2017
    Report Date
    December 28, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML HOSPIRA BAG NDC 0409-4651-13, LOT 67-9191, FW EXP 1 JAN 2018 HAPERIN SODIUM. THE CUSTOMER¿S REPORT OF THE BAG EMPTYING SOONER THAN EXPECTED WAS NOT CONFIRMED. HOWEVER, THE MEMBRANE FRAME WAS OBSERVED TO BE BROKEN AT THE UPPER HINGE POST. PHYSICAL INSPECTION OF THE DEVICE NOTED A CRACK AT THE LOWER DOOR HINGE, THE SEAR STICKING AND NOT SPRINGING BACK INTO POSITION ON ITS OWN, DENTS AND CRACKS IN THE REAR CASE, AND THE MEMBRANE FRAME DAMAGED/CRACKED AT THE UPPER HINGE. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 3:16 AM ON (B)(6) 2017 THE PUMP MODULE WAS PROGRAMMED TO INFUSE HEPARIN 25000UNIT IN 500ML AT A RATE OF 11ML/HR WITH A VTBI OF 450ML. THE DEVICE ALARMED FOR FLO STOP OPEN FOR 4 SECONDS AND THEN THE USER STARTED THE INFUSION. BETWEEN 3:44 AM AND 4:11 AM, THE DEVICE ALARMED 4 TIMES FOR PATIENT SIDE OCCLUSION. EACH TIME THE USER RESTARTED THE INFUSION. BETWEEN 5:34 AM AND 5:45, THE DEVICE ALARMED 2 TIMES FOR AIR IN LINE. EACH TIME THE USER RESTARTED THE INFUSION. AT 5:46 AM, THE USER CHANNELED THE DEVICE OFF AND THE SYSTEM WAS SHUT DOWN AND POWERED DOWN. THE VOLUME RECORDED AS BEING INFUSED WAS 24.33ML. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS DELIVERING FLUID WITHIN SPECIFICATION. THERE WERE NO LEAKS OBSERVED FROM THE PRIMARY SET. THE PROBABLE CAUSE OF THE OVER INFUSION IS THE BROKEN UPPER MEMBRANE FRAME HINGE WHICH CAN CAUSE INTERMITTENT UNREGULATED FLOW DEPENDING ON HOW THE PLATEN POSITIONS ITSELF WHEN THE DOOR IS CLOSED. THE ROOT CAUSE OF THE BROKEN UPPER MEMBRANE FRAME HINGE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 425ML OF HEPARIN WAS PROGRAMMED TO INFUSE AT 11 ML/HR (550 UNITS/HR) HOWEVER AFTER APPROXIMATELY 2.5 HOURS THE BAG WAS NOTED TO BE EMPTY. THE MD WAS NOTIFIED AND STAT LABS WERE TAKEN. AS A RESULT, THE PATIENT WAS GIVEN AN IV DOSE OF PROTAMINE. THERE WAS NO LASTING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50285 ALARIS® PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention