BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2151839 · Received July 6, 2011

    Report

    Report Number
    6000001-2011-10514
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A GRAVITY TEST WAS PERFORMED ON THE SAMPLE USING A METHYLENE BLUE SOLUTION, AND THE RESULTS SHOWED THE UNIT FUNCTIONED CORRECTLY SINCE THE SOLUTION PASSED THROUGH THE SET WITH A NORMAL FLOW. A VISUAL INSPECTION OF THE SAMPLE REVEALED EVIDENCE OF CRUSHED TUBING. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    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 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION OR BLOOD ADMINISTRATION SET IN WHICH THE TUBING WAS DAMAGED BY THE ROLLER CLAMP. ACCORDING TO THE REPORT, WHEN HANDLING THE ROLLER CLAMP, IT CRUSHES THE TUBING (VISIBLE TRACES OF THE ROLLER) AND FLOW GETS UNVERIFIABLE. THE CONDITION WAS IDENTIFIED BEFORE PATIENT USE; THEREFORE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 11D19V100

    Patients

    Seq Age Sex Outcome Treatment
    1