BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY ADMINISTARTION SET

    MDR report key: 3812922 · Received April 25, 2014

    Report

    Report Number
    9616066-2014-00411
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 2, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K820278
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: APRIL 25, 2104. INTERNAL FILE NO: (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, DURING AN ISOLYTES GRAVITY INFUSION WHEN THE PATIENT MOVES AROUND A LOT IT CAUSES TENSION ON THE TUBING AND THE ROLLER CLAMP LOOSENS WHICH CAUSES A FASTER THAN INTENDED INFUSION. THE NURSE MOVED THE ROLLER CLAMP TO THE DIFFERENT LOCATION ON THE SET AND THE INFUSION CONTINUED AT THE INTENDED RATE. THERE WAS NO REPORT OF HARM TO PATIENT OR MEDICAL INTERVENTION. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251188 PRIMARY ADMINISTARTION SET FPA CAREFUSION CORPORATION 10802688 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK