BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PP YSTE MACRO

    MDR report key: 1880828 · Received October 1, 2010

    Report

    Report Number
    9615050-2010-00180
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K971293
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A KNOWN ISSUE AND NO EVAL WILL BE PERFORMED ON THE CUSTOMER'S DEVICE. THE ISSUE OF SPLIT OR BURST TUBING WHEN USING POWER INJECTORS WAS EVALUATED UNDER A FORMAL INVESTIGATION. IT WAS DETERMINED THAT THIS IS NOT A MFG OR MATERIALS DEFECT. IT WAS COMMUNICATED TO THE CUSTOMER THAT STANDARD IV ADMINISTRATION SETS ARE INTENDED FOR GENERAL INFUSION AND NOT RECOMMENDED FOR USE WITH POWER INJECTORS. 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 A TUBING RUPTURE WHILE IN USE WITH A POWER INJECTOR. THE TUBING SET WAS CONNECTED TO AN EXTENSION SET AND WAS BEING USED TO DELIVER 100 ML OF AN UNSPECIFIED CONTRAST MEDIA AT A RATE OF 2.5 ML/SECS. IT WAS REPORTED THAT THE 100 ML WAS TO BE DELIVERED IN 40 SECONDS. IT WAS REPORTED THAT 20 SECOND AFTER THE DELIVERY WAS STARTED, THE TUBING RUPTURED BELOW THE DISTAL PREPIERCED Y-SITE AND AN UNSPECIFIED VOLUME OF BLOOD BACKED UP IN THE TUBING OF THE EXTENSION SET. THE EXTENSION SET WAS CLAMPED. THE RADIOLOGIST REVIEWED THE CT SCAN AND DETERMINED THAT A REPEAT SCAN WAS NOT NECESSARY; THEREFORE, THE TUBING SET WAS NOT REPLACED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE PT WAS DISCHARGED HOME FOLLOWING THE PROCEDURE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PP YSTE MACRO 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR UNSPECIFIED POWER INJECTOR, MFR UNK| UNSPECIFIED CONTRAST MEDIA, MFR UNK| LIFESHIELD EXTENSION SET, LIST #14929, LOT #UNK