BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 3770040 · Received January 28, 2014

    Report

    Report Number
    9615050-2014-00718
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED YET. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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. ON AN UNSPECIFIED DATE, THE CUSTOMER CONTACT REPORTED A LEAK AT AN UNSPECIFIED LOCATION OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. NO INFORMATION WAS PROVIDED IF THE LEAK OCCURRED DURING OR PRIOR TO PATIENT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60876 PLM LFS PRIM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 251595H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK