BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2222983 · Received August 10, 2011

    Report

    Report Number
    9613251-2011-00167
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 MFR 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 INJECTORS. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR 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. THE CUSTOMER CONTACT REPORTED THAT DURING A CT SCAN, THE TUBING SET HAD BEEN USED TO DELIVER AN UNSPECIFIED VOLUME OF ISOVUE 370 CONTRAST MEDIUM, AT A RATE OF 2ML/SEC, VIA A POWER INJECTOR. THE MALE ADAPTER OF AN UNSPECIFIED POWER INJECTOR TUBING WAS CONNECTED TO THE CLAVE PORT OF THE TUBING SET. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT¿S IV ACCESS SITE. AFTER THE INJECTION OF THE CONTRAST MEDIUM WAS COMPLETE, THE TUBING SET WAS THEN USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA POWER INJECTOR. AFTER AN UNSPECIFIED LENGTH OF TIME DURING THE NORMAL SALINE INJECTION, THE TUBING RUPTURED BETWEEN THE OPTION-LOK MALE ADAPTER AND THE CLAVE PORT. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. THE TUBING WAS CLAMPED USING THE SLIDE CLAMP. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSLF EXT SET W CLV 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 BRACCO DIAGNOSTICS, INC.: INSOVUE 370| MEDRAD, INC.: UNSPECIFIED POWER INJECTOR