BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6707957 · Received July 12, 2017

    Report

    Report Number
    2016493-2017-00437
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 23, 2017
    Report Date
    June 23, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT THE PUMP INFUSED A GREATER VOLUME THAN THE CONTENTS OF A 520ML BAG OF PACLITAXEL WAS CONFIRMED VIA LOG ANALYSIS. THE SECONDARY BAG LABEL INDICATED A TOTAL VOLUME OF 520ML BUT THE ASSOCIATED PCU LOG RECORDED A TOTAL INFUSED VOLUME OF 699.96ML. THE REPORT THAT SALINE WAS INFUSING FROM THE PRIMARY BAG EVEN THOUGH IT WAS MOUNTED ONE RUNG LOWER THAN THE PACLITAXEL BAG (ASSUMED TO MEAN 1 HANGER LENGTH) COULD NOT BE CONFIRMED; NO HANGER WAS RECEIVED AND THE CUSTOMER PROVIDED NO EVIDENCE OF THE ACTUAL SETUP. TESTING AND INSPECTION IDENTIFIED NO ISSUES. THE SYSTEM WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. SYMPATHETIC FLOW FROM THE PRIMARY BAG WHEN IT WAS HUNG WITH ONE HANGER WAS REPLICATED WHEN TESTING WITH THE SECONDARY SET ROLLER CLAMP PARTIALLY CLOSED. THE SYMPATHETIC FLOW STOPPED WHEN A SECOND HANGER WAS ATTACHED, DOUBLING THE DISTANCE BETWEEN THE PRIMARY AND SECONDARY BAGS. BASED ON THIS TEST RESULT THE ROLLER CLAMP MAY HAVE BEEN PARTIALLY CLOSED DURING THE REPORTED INFUSION OR THERE MAY HAVE BEEN AN OBSTRUCTION PRESENT IN THE SECONDARY SIDE THAT WAS COMPROMISING SECONDARY FLOW. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A 500ML BAXTER BAG NDC 0038-0049-03, LOT NUMBER Y231910 EXP JUL 18 0.9% SODIUM CHLORIDE; NON-BD SECONDARY SET WITH 500ML B.BRAUN BAG NDC 0264-7510-10 LOT NUMBER J6N114 EXP 04/19 5% DEXTROSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PUMP READ A GREATER VOLUME INFUSED THAN A 520 ML BAG OF PACLITAXEL. THE INFUSION STARTED AT 11:35AM AND AT 2:48PM THE PUMP READ 556ML INFUSED WITH WHAT APPEARED TO BE 100MLS LEFT IN THE PACLITAXEL BAG. THERE WAS A NORMAL SALINE BAG FLOWING DESPITE BEING MOUNTED ONE RUNG LOWER THAN THE PACLITAXEL. THE NORMAL SALINE WAS PUT ON A SECOND HANGER THEN THE PACLITAXEL FINISHED INFUSING. THERE IS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PUMP READ A GREATER VOLUME INFUSED THAN A 520MLS BAG OF PACLITAXEL 300MG/50ML. THE SECONDARY INFUSION STARTED AT 11:35AM AT A RATE OF 173 ML/HR AND AT 2:48PM THE PUMP READ 556MLS INFUSED WITH WHAT APPEARED TO BE 100MLS LEFT IN THE PACLITAXEL BAG. THERE WAS A NORMAL SALINE BAG FLOWING DESPITE BEING MOUNTED ONE RUNG LOWER THAN THE PACLITAXEL. THE NORMAL SALINE WAS PUT ON A SECOND HANGER THEN THE PACLITAXEL FINISHED INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487515 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR