BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082333 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03814
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: AN ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE TUBE WAS RUPTURED APPROXIMATELY 10CM ABOVE THE LUER LOCK. THE CAUSE OF THIS CONDITION WAS DUE TO A HIGH PRESSURE IN THE SET.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF 3 ADMINISTRATION SETS THAT RUPTURED DURING THE INJECTION OF A CONTRAST PRODUCT THROUGH A POWER INJECTOR. ACCORDING TO THE REPORTER, DURING A SCANNER SESSION, WHEN INJECTING IODE AT THE RATE OF 3ML/SEC AND WITH A PRESSURE THAT DID NOT EXCEED 123 PSI, THE INLET RUPTURE 10 CM ABOVE THE CATHETER. REPORTEDLY, THE RUPTURE OCCURED 3 MINUTE AFTER THE INJECTION STARTED. THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT BUT BLOOD SPREAD ON THE PATIENT, THE SCANNER HAS TO BE STOPPED AND RESTARTED WITH A NEW SET WHICH MEANS MORE RAY EXPOSURE FOR THE PATIENT THAN INITIALLY EXPECTED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1 IODE CONTRAST, POWER INJECTOR