BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NDEHP PRIMARY PLUM CLAVE Y

    MDR report key: 1813950 · Received August 18, 2010

    Report

    Report Number
    9615050-2010-00158
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 12030. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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 AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE FOLLOWING THE TUBING SET NEEDED TO BE REFLUSHED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT, "THE CHAMBER OF THE TUBING (CASSETTE) EMPTIED AND NEEDED TO BE REFLUSHED. THIS INDUCED A DROP OF ARTERIAL PRESSURE." NO SPECIFIC PT INFO OR EVENT DETAILS WERE AVAILABLE. THE TUBING SET AND PUMP WERE REPLACED AND THE THERAPY WAS RESUMED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO, INCLUDING SPECIFIC PT INFO, CLARIFICATION OF EVENT DETAILS, BLOOD PRESSURE MEASUREMENTS, AND PT OUTCOME HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM CLAVE Y UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LIST # UNK| SN UNK| PLUM PUMP