BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 7207014 · Received January 19, 2018

    Report

    Report Number
    2016493-2018-00075
    Event Type
    Death
    Date Received
    January 19, 2018
    Date of Event
    December 26, 2017
    Report Date
    December 28, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (2)2200-0500; 30822; 20062E, (2) 500ML BAXTER BAG; (2) BAXTER BURETTE SET; (5) NON BD EXTENSION SET; (2) 10ML BD SYRINGE. THE CUSTOMER REQUESTED A DEVICE EVALUATION FOR THE PERIOD BETWEEN 0700 AND 1000 ON (B)(6) 2017. THE PCU EVENT LOG SHOWS THAT AT 6:40 AM ON (B)(6) 2017, PUMP MODULE S/N (B)(4) (UNIT B) WAS IN USE AND INFUSING TPN ¿ NICU AT 5ML/HR WHICH CONTINUED UNTIL 10:02 AM WHEN THE DEVICE WAS CHANNELED OFF. THE ONLY ALARM FOR THIS MODULE DURING THIS PERIOD WAS FOR A PATIENT SIDE OCCLUSION ALARM AT 8:24 AM. THE PCU EVENT LOG SHOWS THAT AT 6:40 AM ON (B)(6) 2017, PUMP MODULE S/N (B)(4) (UNIT C) WAS IN USE AND INFUSING IVF AT 1ML/HR WHICH CONTINUED UNTIL 10:02 AM WHEN THE DEVICE WAS CHANNELED OFF. THERE WERE NO ALARMS OR ERRORS FOR THIS MODULE DURING THIS PERIOD. FUNCTIONAL TESTING OF THE RETURNED PUMP MODULES SHOWS THAT BOTH DEVICES WERE ABLE TO DETECT AND ALARM FOR A SINGLE AIR BOLUS AT THE CUSTOMER'S 50 UL SETTING AS WELL AS ALARM FOR ACCUMULATED AIR. THERE WERE NO ANOMALIES OBSERVED WITH THE RETURNED PRIMARY SETS AND THERE WERE NO LEAKS OBSERVED FROM EITHER SET. THERE WERE ALSO TWO CONCOMITANT SYRINGE MODULES IN USE DURING THE REPORTED TIME FRAME. SYRINGE MODULES CANNOT DETECT AIR IN LINE. THERE WERE NO ALARMS OR ERRORS ON EITHER SYRINGE MODULE FOR THE REVIEW PERIOD REQUESTED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (2)SYRINGE TUBING; (2)PRIMARY TUBING. 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

    THE MEDICATIONS INFUSING WERE INFANT TPN 120 ML AT 5 ML/HR, LIPIDS 20%, AN UNSPECIFIED MEDICATION IN A SYRINGE, AND SODIUM ACETATE CONTAINING HEPARIN 125 UNITS AT 1 ML/HR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ECHOCARDIOGRAM WAS PERFORMED, AIR WAS NOTED IN THE HEART, AND FOLLOWING THE ECHOCARDIOGRAM, THE PATIENT CODED AND DIED. FOUR MODULES WERE IN USE AT THE TIME OF THE EVENT. TPN, LIPIDS, AN UNSPECIFIED MEDICATION IN A SYRINGE, AND SODIUM ACETATE WERE INFUSING. THERE WAS NO INDICATION OF AIR IN THE IV TUBING. THE CUSTOMER DOES NOT ALLEGE A DEVICE ISSUE CAUSED THE PATIENT DEMISE. AN EVALUATION OF THE DEVICES AND ADMINISTRATION SETS WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50224 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death 8100, 8015, (2)8110, EVENT DATE (B)(6)