BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NDEHP PRM MICDRP CLV

    MDR report key: 2051036 · Received April 4, 2011

    Report

    Report Number
    9613251-2011-00054
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE TUBING SET WAS BEING USED TO DELIVER 600ML OF 5% DEXTROSE WITH AN UNSPECIFIED CONCENTRATION OF POTASSIUM CHLORIDE. THE CAIR CLAMP WAS BEING USED TO REGULATE THE FLOW. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE PT RECEIVED A 600ML "FLUSH" OF SOLUTION. THE PHYSICIAN WAS NOTIFIED. THE PT WAS TREATED WITH LASIX 40MG. THE PHYSICIAN ALSO ORDERED BLOOD WORK TO BE DRAWN. NO RESULTS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THERE WAS "NO SEVERE CONSEQUENCES TO PT, REPORTED ONLY 'MINOR' AND CORRECTED RAPIDLY BY THE NURSE AND DOCTOR OF THE ICU." THE CUSTOMER CONTACT REPORTED THAT "AFTER INVESTIGATION THE ROLLER CLAMP WAS NOT DIMINISH ENOUGH." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRM MICDRP CLV 80FPA FPA HOSPIRA LTD. NA 931934W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention