BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 1.2 MICRN ASV

    MDR report key: 3970703 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03086
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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 A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF AN UNSPECIFIED TOTAL PARENTERAL NUTRITION (TPN). NO SPECIFIC PUMP PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED A LEAK AT THE LEVEL OF THE FILTER OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MED INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255506 GEMSTR 1.2 MICRN ASV 80FRN FRN HOSPIRA COSTA RICA LTD. NA 241815H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK