BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACR LKN

    MDR report key: 2335684 · Received October 31, 2011

    Report

    Report Number
    9613251-2011-00217
    Event Type
    Malfunction
    Date Received
    October 31, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 3, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE RPTR WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFO WAS NOT OBTAINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED ANTIBIOTIC, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED PRIMARY TUBING SET. IT WAS REPORTED THAT AFTER THE DELIVERY OF THE ANTIBIOTIC WAS STARTED, NO FLOW OF SOLUTION WAS NOTED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. IT WAS REPORTED THAT THE PT REMAINED STABLE. NO MEDICAL INTERVENTIONS WERE REQUIRED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO INCLUDING EVENT DETAILS, IF THE TUBING SET WAS REPLACED AND THERAPY RESUMED, AND REPROCESSING OF THE TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONV PN SEC MACR LKN 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CAREFUSION| UNSPECIFIED ALARIS PRIMARY TUBING SET, MFR BY| UNSPECIFIED ALARIS PUMP, MFR BY CAREFUSION