BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVPRM PB CLV OL100IN

    MDR report key: 1802458 · Received August 6, 2010

    Report

    Report Number
    9613251-2010-00096
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 9, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4). ADD'L INFO FROM THE USER FACILITY REPORT: LIFESHIELD/HOSPIRA. IV SET. LIFESHIELD/HOSPIRA.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH REC'D THAT STATED: "SALINE IN FLUSH BAG WAS RUNNING INSTEAD OF CHEM DESPITE CLAMPING EARLIER IN THE INFUSION. THE CLAVE WAS FOUND TO HAVE MALFUNCTIONED AND THE INTERNAL MECHANISM DID NOT RESET AND WAS DEPRESSED PERMANENTLY ALLOWING FLUID FLOW." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THE CLAVE Y-SITE REMAINED IN THE OPEN POSITION AND UNRESTRICTED FLOW WAS NOTED. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AT AN UNSPECIFIED TIME, AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE UPPER CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF AVASTIN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THE PRIMARY TUBING SET TUBING WAS CLAMPED USING THE FORK CLAMP ON THE BACK CAIR CLAMP; HOWEVER, IT WAS REPORTED THAT THE NORMAL SALINE CONTINUED TO FLOW FROM THE PRIMARY LINE. ADDITIONALLY, IT WAS REPORTED THAT AFTER THE MALE ADAPTER OF THE SECONDARY TUBING SET WAS REMOVED FROM THE UPPER CLAVE Y-SITE ON THE PRIMARY TUBING SET, LEAKAGE OF SALINE WAS NOTED FROM THE CLAVE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THE PT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING WHAT STEPS WERE TAKEN BY THE USER FACILITY WHEN THE CONTINUATION OF FLOW AND THE LEAKAGE WAS NOTED, IF THERAPY WAS RESUMED USING A REPLACEMENT DEVICE, AND IF ANY MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVPRM PB CLV OL100IN 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR SECONDARY TUBING SET: MFR UNK