BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6579017 · Received May 19, 2017

    Report

    Report Number
    2016493-2017-00351
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    April 29, 2017
    Report Date
    May 10, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION ON FOLLOW-UP(1): (DISREGARD SEC TUBING). THE CUSTOMER¿S REPORT OF VANCOMYCIN INFUSING FASTER THAN EXPECTED WAS NOT CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN FAIR CONDITION WITH A CRACKED BEZEL AT THE LOWER HINGE AND DRIED FLUID RESIDUE FILM OBSERVED ON THE IUI PINS. ANALYSIS OF THE PCU EVENT LOG IDENTIFIED AN INFUSION OF DRUG ID 196 (VANCOMYCIN 1GRAM/250ML) WAS PROGRAMMED AS A PRIMARY INFUSION WITH A RATE OF 250ML/HOUR VTBI 250ML. THERE WERE NO OBVIOUS PROGRAMMING ERRORS OBSERVED. THE LOG SHOWED THAT THE INFUSION STOPPED AFTER THE LVP ALARMED WITH AN ¿INFUSOR DOOR OPEN¿ FOLLOWED BY A ¿CHECK IV SET¿ 12 MINUTES AFTER INITIATION OF THE VANCOMYCIN. THE LOGS SHOW ONE ATTEMPT TO PROGRAM DRUG ID 196; HOWEVER THE PROGRAMMING WAS NOT COMPLETED AND THE LVP WAS CHANNELED OFF. RATE ACCURACY TESTING WAS PERFORMED AND THE DEVICE WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS WITH NO ANOMALIES OBSERVED. NO IRREGULARITIES WAS OBSERVED WITH THE PRIMARY SET. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF VANCOMYCIN INFUSING FASTER THAN EXPECTED WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1G VIAL VANCOMYCIN NDC 0409-6533-01, LOT 59335DD, EXP 1 NOV 2017; 250ML BAXTER BAG NDC 0338-0049-02, LOT NUMBER Y230946, EXP OCT 18, 0.9% NACL. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SECONDARY INFUSION OF VANCOMYCIN 1 GRAM IN 250 ML 0.9% SODIUM CHLORIDE WAS TO INFUSE AT 250 ML/HR. HOWEVER, THE CUSTOMER REPORTED THE 250 ML BAG EMPTIED WITHIN 25 MINUTES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A 250ML INFUSION OF 0.9% NACL WITH 1G OF VANCOMYCIN WAS PROGRAMMED TO INFUSE AT 250ML/HR HOWEVER AFTER APPROXIMATELY 25 MINUTES THE INFUSION WAS COMPLETE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360161 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1