BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SET-PRIMARY DRUGADMIN. SET

    MDR report key: 1932607 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06016
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    April 22, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. ONE UNIT WAS RECEIVED AT THE PLANT FOR EVALUATION. THE UNIT WAS TESTED UNDER WATER USING 0.56 BAR OF AIR PRESSURE AND THE BLOCKAGE REPORTED BY THE CUSTOMER WAS CONFIRMED AT THE CHECK VALVE LEVEL. THE VISUAL INSPECTION REVEALED THAT THE NYPRO CHECK VALVE WAS INVERTED WHICH EXPLAIN THE BLOCKAGE OF THE UNIT SINCE THIS COMPONENT FUNCTIONS IN ONE WAY. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CONTINU-FLO SET WHERE THE "LINE WAS BLOCKED" PRIOR TO PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SET-PRIMARY DRUGADMIN. SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 08J05V036

    Patients

    Seq Age Sex Outcome Treatment
    1