BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM/APM 5 MICRON FLT

    MDR report key: 3102445 · Received May 2, 2013

    Report

    Report Number
    9615050-2013-01024
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K923601
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PROPOFOL, AT AN UNSPECIFIED RATE, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PHYSICIAN NOTED A LEAK OF AN UNSPECIFIED VOLUME OF SOLUTION AT AN UNSPECIFIED LOCATION OF THE FILTER OF THE TUBING SET. THE TUBING SET AS REPLACED AND THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192963 AIM/APM 5 MICRON FLT 80FRN FRN HOSPIRA COSTA RICA LTD. NA 102105H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK