BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 2862168 · Received December 5, 2012

    Report

    Report Number
    9615050-2012-01466
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PROPOFOL, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION ON THE TUBING SET. THE CUSTOMER CONTACT REPORTED THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED THAT THERE WAS A DELAY IN THERAPY WHILE THE TUBING SET WAS BEING REPLACED; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA 161725H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK