BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM/APM TUBING SET WITH 1.2 MICON FILTER

    MDR report key: 1181637 · Received September 30, 2008

    Report

    Report Number
    9613251-2008-00349
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    April 4, 2008
    Report Date
    September 9, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K934671
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY THE HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. PRIOR TO PATIENT USE WHILE PRIMING THE TUBING SET WITH AN UNSPECIFIED SOLUTION, THE TUBING SEPARATED FROM THE FILTER. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIM/APM TUBING SET WITH 1.2 MICON FILTER 80-FRN FRN HOSPIRA LTD. NA 521804W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA