BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM/APM 5 MICRON FLT

    MDR report key: 3853438 · Received April 4, 2014

    Report

    Report Number
    9615050-2014-02527
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 27, 2014
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THE SEMI-RIGID FEMALE ADAPTER OF THE INLET PORT OF THE AIR ELIMINATING FILTER WAS BROKEN OFF. WHITE DRAG MARKS WERE NOTED INDICATING THE USE OF FORCE. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS SIMILAR COMPLAINTS DUE TO BROKEN PORTS ON THE IV FILTER. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO APPLICATION OF PERPENDICULAR FORCE ON THE PORTS OF THE FILTER. 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 TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE SEMI-RIGID FEMALE ADAPTER OF THE AIR ELIMINATING FILTER OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205125 AIM/APM 5 MICRON FLT 80FRN FRN HOSPIRA COSTA RICA LTD. NA 111545H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA