BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADMINISTRATION SET WITH 1.2MIC FILTER

    MDR report key: 1983386 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00821
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    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). A CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR AN EVALUATION. A VISUAL INSPECTION REVEALED THAT THE SET WAS FILLED WITH WHITE SOLUTION AND WAS FULL OF MOLD. THE SOLUTION WAS FLUSHED FROM THE SETS WITH NO DIFFICULTIES BY CONNECTING THE SET TO AN AIR PRESSURE OF 0.56 BAR. THE SET WAS CONNECTED TO A VIAFLO BAG FILLED WITH SODIUM CHLORIDE BUT THE SOLUTION WAS STOPPING AT THE CHAMBER LEVEL HENCE REPORTED PROBLEM WAS CONFIRMED. THE NUTRIVEX FILTERS USED ON THIS CODE ARE PURCHASED FROM AN EXTERNAL SUPPLIER. SINCE THE EXACT ROOT CAUSE FOR THE REPORTED NON-CONFORMANCE COULD NOT BE DETERMINED AT PLANT LEVEL, FURTHER EVALUATION IS NEEDED AT THE SUPPLIER. FURTHERMORE, BAXTER SHALL KEEP MONITORING THESE EVENTS DURING QUALITY REVIEWS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN 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 AN ADMINSTRATION SET THAT HAD A BLOCKAGE IN THE FILTER WHEN ATTEMPTING TO PRIME THE SET. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION ADMINISTRATION SET WITH 1.2MIC FILTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10D30V300D

    Patients

    Seq Age Sex Outcome Treatment
    1