BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF REG EXT SET NON-DEHP

    MDR report key: 3821124 · Received April 16, 2014

    Report

    Report Number
    9613251-2014-00082
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 19, 2014
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SEALED DEVICE WAS REC'D AND EVALUATED. THE DEVICE PASSED TESTING. NO TUBING SEPARATIONS WERE NOTED. ALTHOUGH THE DEVICE PASSED TESTING, DURING THE INVESTIGATION, A PROBABLE CAUSE FOR THE CUSTOMER REPORTED SEPARATION WAS IDENTIFIED. THE PROBABLE CAUSE OF THE SEPARATION COULD HAVE BEEN DUE TO INSUFFICIENT SOLVENT APPLICATION DURING MFG. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT REC'D OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF SEPARATIONS. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED CONCENTRATIONS OF VANCOMYCIN VIA GRAVITY. AFTER UNSPECIFIED LENGTHS OF TIMES AFTER THE DELIVERIES WERE STARTED, THE TUBING SEPARATED FROM THE OUTLET PORT ON THE DIAL-A-FLOW OF THE TUBING SETS AND UNSPECIFIED VOLUMES OF SOLUTION LEAKED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232684 LS LF REG EXT SET NON-DEHP 80FPK FPK HOSPIRA, LTD NA 340324W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK