BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3860563 · Received April 15, 2014

    Report

    Report Number
    9615050-2014-02678
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT INDICATED THAT THE LOT NUMBER THAT WAS IN USE WAS 2019.0209.13; HOWEVER, THIS LOT NUMBER CANNOT BE VERIFIED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNABLE TO PRIME. THE CUSTOMER CONTACT REPORTED THAT DURING PRIMING OF THE TUBING SET WITH AN UNSPECIFIED VOLUME OF NORMAL SALINE PRIOR TO PATIENT USE, THE DEVICE WAS UNABLE TO BE PRIMED. THE CUSTOMER CONTACT REPORTED THAT AFTER SETTING UP THE INFUSION AND LOADING THE CASSETTE INTO THE PUMP, THE PUMP WAS TRYING TO PRIME THE DEVICE; HOWEVER, NO FLOW OF SOLUTION WAS NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230576 UNK UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA UNSPECIFIED 100ML SOLUTION CONTAINER,| MANUFACTURED BY BAXTER, INC.