BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE PUMP SETS WITH CARESITE

    MDR report key: 3973123 · Received June 5, 2014

    Report

    Report Number
    9614279-2014-00027
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TUBING SET, WITH PACKAGING IDENTIFYING THE REPORTED LOT NUMBER 0061353560, WAS RECEIVED FOR EVALUATION. THE RETURNED SET WAS SUBJECTED TO OCCLUSION AND AIR PRESSURE (LEAKAGE) TESTS ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THE SET WAS THEN SPIKED, PRIMED, AND LOADED INTO AN INFUSOMAT SPACE PUMP ((B)(4)) AS PER THE INSTRUCTIONS FOR USE. A SECONDARY SET WAS THEN CONNECTED TO THE CARESITE AND THE PUMP WAS ALLOWED TO RUN FOR ONE HOUR. DURING THIS TIME, THERE WAS NO BUBBLES OR AIR COLUMNS OBSERVED IN ANY LOCATION OF THE TUBING SET. REVIEW OF THE DISCREPANCY MGMT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED SAMPLE MET REQUIREMENTS ACCORDING TO SPECIFICATION. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE CHEMO RN SET UP A D5W LINE AT 30 ML/HR ON AN INFUSOMAT PUMP. THE RN THEN SET UP A 2ND IDENTICAL SET WITH IVIG ON AN INFUSOMAT PUMP AT 300 ML/HR AND CONNECTED IT INTO THE DISTAL CARESITE OF THE D5W LINE. WHEN THE RN CONNECTED THE LINE, OR WHEN SHE STARTED THE 2ND PUMP, SHE SAW MULTIPLE 1/2 INCH (VARIABLE) COLUMNS OF AIR ENTER THE D5W TUBING AT REGULAR INTERVALS. THE INFUSION WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328619 INFUSOMAT SPACE PUMP SETS WITH CARESITE SPACE PUMP IV SET W/2 CARESITES AND ASV FPA B. BRAUN OF DOMINICAN REPUBLIC NA 0061353560

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFUSOMAT SPACE PUMP