BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE NDHP MICR

    MDR report key: 2191412 · Received July 27, 2011

    Report

    Report Number
    9613251-2011-00164
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 30, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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 I.V ADMINISTRATION SETS ARE INTENDED FOR GENERAL INFUSION AND NOT RECOMMENDED FOR USE WITH POWER INJECTIONS. 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; SUBSEQUENTLY BLOOD LOSS WAS NOTED. IT WAS REPORTED THAT DURING THE PT'S CT SCAN, THE TUBING SET WAS BEING USED TO DELIVER 90ML OF OMNIPAQUE 350, AT A RATE OF 4ML/MIN, VIA A POWER INJECTOR. THE MALE ADAPTER OF AN UNSPECIFIED POWER INJECTOR TUBING WAS CONNECTED TO THE CLAVE PORT OF THE TUBING SET. THE SPIN-LOC MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT'S IV ACCESS SITE. AFTER AN UNSPECIFIED LENGTH OF TIME DURING THE CONTRAST INJECTION, THE TUBING RUPTURED BETWEEN THE SPIN-LOC MALE ADAPTER AND THE CLAVE PORT. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. IT WAS REPORTED THAT FOR AN UNSPECIFIED REASON, THE PT'S IV CATHETER WAS REMOVED AND A NEW ACCESS SITE WAS ESTABLISHED. THE TUBING SET WAS REPLACED; HOWEVER, THE PT REFUSED TO REPEAT THE PROCEDURE. THE PT WAS TRANSFERRED TO THE EMERGENCY DEPT. IT WAS REPORTED THAT THE PT RETURNED TO THE RADIOLOGY DEPT THE FOLLOWING DAY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE NDHP MICR 80FPA FPA HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR OMNIPAQUE 350 CONTRAST MEDIUM, MFR AMERSHAM HLTH.| STELLANT POWER INJECTOR, MFR MEDRAD