BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3935523 · Received July 15, 2014

    Report

    Report Number
    1416980-2014-22647
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE IS REPORTED TO BE UNAVAILABLE FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED AND WILL BE EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED NO FLOW WAS DETERMINED TO BE A USE ERROR. IT WAS REPORTED THAT THE UNUSED SECOND LEAD OF THE DEVICE WAS NOT PRIMED. ACCORDING TO THE DEVICE LABELING THE USER IS INSTRUCTED TO PRIME AN UNUSED LEAD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PHYSICAL SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. DURING PHOTOGRAPHIC INSPECTION, AIR WAS IDENTIFIED IN THE FILTER AND TUBING OF THE DEVICE. A REVIEW OF THE DIRECTIONS FOR USE SECTION OF THE LABELING WAS PERFORMED. THE CAUSE OF THE AIR IN THE DEVICE WAS UNABLE TO BE DETERMINED. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE AND ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SECOND CHAMBER OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET FILLED WITH AIR AND WOULD NOT DRIP. THE REPORTER STATED THAT THE TOP CHAMBER WAS FULL WHILE THE BOTTOM CHAMBER ¿WAS JUST SUCKING AIR.¿ THIS OCCURRED DURING A BLOOD TRANSFUSION, WHEN THERE WAS APPROXIMATELY 15 MINUTES LEFT IN THE PROCEDURE. THE SECOND LEAD OF THE SET WAS NOT BACK PRIMED AND NO SALINE BAG WAS HUNG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412889 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1