BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3073114 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10089
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.EVALUATION SUMMARY:BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A MISSING ROLLER WAS CONFIRMED. VISUAL INSPECTION OF THE DEVICE NOTED THAT THE ROLLER IS MISSING FROM THE CLAMP. THE ROLLER CLAMP IS ASSEMBLED VIA MACHINE AND A SENSOR CHECKS FOR THE PRESENCE OF A ROLLER IN THE CLAMP. THE SENSOR WAS CHECKED AND FOUND TO BE FUNCTIONING CORRECTLY. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE ROLLER CLAMP OF A SOLUTION ADMINISTRATION SET HAD A MISSING ROLLER. THIS CONDITION OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173394 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 13B28V478

    Patients

    Seq Age Sex Outcome Treatment
    1