BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2981487 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04846
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. INITIAL INSPECTION DID NOT CONFIRM THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO FAULTS WERE FOUND. FUNCTIONAL TESTS WERE PERFORMED. A LEAK TEST WAS CARRIED OUT UNDER WATER AT 8 PSI FOR MORE THAN 5 MINUTES, THERE WAS NO EVIDENCE OF A LEAK, AND THE ROLLER CLAMP WAS FOUND TO BE FUNCTIONAL. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT A BURETROL SET HAD A ROLLER CLAMP THAT DID NOT CLOSE. THE CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84738 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SX12IB9

    Patients

    Seq Age Sex Outcome Treatment
    1