BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS SPRIM PMP

    MDR report key: 2854543 · Received November 29, 2012

    Report

    Report Number
    9615050-2012-01435
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED SOLUTION. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, THE TUBING SEPARATED FROM AN UNSPECIFIED LOCATION ON THE FILTER OF THE TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM LFS SPRIM PMP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 113075H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA