BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN (48/CASE)

    MDR report key: 3231087 · Received July 12, 2013

    Report

    Report Number
    9615050-2013-02022
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. AT AN UNSPECIFIED TIME, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT APPROXIMATELY 20-30 MINUTES AFTER THE TUBING SET WAS PRIMED PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE AIR FILTER AT THE DISTAL END OF THE TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323500 DC PLUM W/SEC CONVPN (48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA 181545H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA