BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 7311531 · Received March 2, 2018

    Report

    Report Number
    2016493-2018-00223
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 13, 2018
    Report Date
    February 16, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-BD SECONDARY SET; (ADDITIONAL)2420-0007; 1000ML BAXTER BAG NDC 0038-0049-04 LOT NUMBER 253781 EXP MAY 19 0.9% SODIUM CHLORIDE; 100ML BAXTER BAG NDC 033-0049-18 LOT NUMBER P373068 EXP JUL 19 MESNA SODIUM CHLORIDE; TEVADAPTOR; NON BD ADAPTER; 1000ML BAXTER BAG NDC 0038-0017-04 LOT NUMBER Y251561 EXP MAY 19 5% DEXTROSE 5% AND DEXORUBCIN. THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE WITH A DOXORUBICIN INFUSION WITH RATE OF 43ML/HR AND INFUSION DURATION OF 24HRS, WHERE THE BAG WAS FOUND EMPTY AFTER INFUSING 4.3 HOURS WAS NOT DEFINITIVELY CONFIRMED IN THE INVESTIGATION. ALTHOUGH THE BAG WAS FOUND TO BE EMPTY UPON RECEIPT AT BD, THE STARTING VOLUME IN THE BAG COULD NOT BE DETERMINED DURING THE INVESTIGATION. THE LOG REVIEW IDENTIFIED AN INFUSION OF DRUG ID 239 (DOXORUBICIN) INFUSION WITH A RATE OF 43ML/HR AND VTBI OF 1025ML THAT WAS RESTORED ON 13FEBRUARY AT 5:24 PM. THE INFUSION WAS STOPPED WHEN THE SOURCE LVP S/N (B)(4) ALARMED WITH AN ¿AIR IN LINE¿. ATTEMPTS WERE MADE TO RESTART AND TO RESTORE THE INFUSION BUT THE DEVICE CONTINUED TO ALARM FOR ¿AIR IN LINE¿. THE SOURCE LVP WAS THEN CHANNELED OFF. TESTING PERFORMED ON THE SOURCE LVP FOUND THE DEVICE OPERATING IN SPECIFICATIONS. TESTING PERFORMED ON THE RETURNED ADMINISTRATION SETS FOUND NO ANOMALIES. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 1000 ML OF DOXORUBICIN WAS PROGRAMMED TO INFUSE AT 43 ML/HR FOR 24 HOURS AND WAS DOUBLE VERIFIED BY 2 RNS. APPROXIMATELY 4.38 HOURS LATER THE BAG WAS NOTED TO BE EMPTY. THE SECOND PUMP WAS INFUSING IFOSFAMIDE FOR A DURATION OF 2 HOURS. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 1000ML OF DOXORUBICIN (50MG/25 ML) WAS PROGRAMMED TO INFUSE AT 43ML/HR FOR 24 HOURS AND WAS DOUBLE VERIFIED BY 2 RNS. APPROXIMATELY 4.38 HOURS LATER THE BAG WAS NOTED TO BE EMPTY. THE SECOND PUMP WAS INFUSING 100ML OF IFOSFAMIDE (2000MG) IN 0.9%NS FOR A DURATION OF 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153408 ALARIS® PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1