BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP/GRAVITY SOLUTION NO 'Y' SITE

    MDR report key: 2002021 · Received February 27, 2011

    Report

    Report Number
    6000001-2011-01370
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SET WAS ATTACHED TO A VIAFLO BAG AND NO BLOCKAGES WERE FOUND. THE SODIUM CHLORIDE FLOWED THROUGH ALL THE TUBING, HENCE THE REPORTED PROBLEM COULDN'T BE CONFIRMED SINCE IT WAS NOT REPRODUCED. DUE TO THE FACT THAT THE ISSUE WAS NOT CONFIRMED AFTER SAMPLE INVESTIGATIONS, THE EXACT ROOT CAUSE THAT HAS LEAD TO THIS REPORTED NON-CONFORMANCE COULDN'T BE DEFINITELY ESTABLISHED. TREND REVIEW PERFORMED ON THIS CODE REVEALED THAT NO OTHER SIMILAR COMPLAINTS WERE RECEIVED IN THE PAST SIX MONTHS. A BATCH FILE REVIEW DID NOT REVEAL ANY ISSUES RELATED TO THIS COMPLAINT AND HAS PASSED ALL STATISTICAL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. 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 ADMINISTRATION SET THAT WOULD NOT FLOW AFTER HAVING FILLED THE RESERVOIR. THE DRUG, PRIVIGEN, AN IVIG PRODUCT, DID NOT FLOW FURTHER INTO THE TUBING WHILE ATTEMPTING TO PRIME THE SET. THERE WAS NO PATIENT NOR MEDICAL INTERVENTION INVOLVED WITH THIS INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 8 OF 16 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP/GRAVITY SOLUTION NO 'Y' SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 08D16V249

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIVIGEN