BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION ADMINISTRATION SET

    MDR report key: 1901789 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04946
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    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

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(6) 2010. AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED ON THE SAMPLE AND FOUND NO ABNORMALITIES. THE SAMPLE WAS THEN SUBMITTED TO UNDERWATER LEAK TESTING, AND A LEAK WAS REVEALED FROM BETWEEN TUBE TO CHAMBER. UPON FURTHER INVESTIGATION IT WAS REVEALED THAT THE LEAK OCCURRED DUE TO A DAMAGED CHAMBER PIP. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH TIER II (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES 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

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION ADMINISTRATION SET WITH A LEAK AT THE JUNCTION OF THE TUBING AND THE DRIP CHAMBER. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING PRIMING BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 2 OF 2 FOR THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUTION ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10D30V254D

    Patients

    Seq Age Sex Outcome Treatment
    1