BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2122363 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07581
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 18, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SAMPLE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MEDWATCH REPORT TO THE FDA IN WHICH THE FDA THEN CONTACTED BAXTER PRODUCT SURVEILLANCE OF A CLEARLINK BLOOD SET TUBING THAT BROKE AT THE POINT WHERE IT GETS THINNER UNDER THE FILTER. THE TUBING WAS CLAMPED AND BEING REMOVED FROM THE PUMP WHEN IT BROKE AND BLOODY SALINE SPILLED ALL OVER THE EMPLOYEE. IT WAS NOT CUT OR HANDLED ROUGHLY. THIS CONDITION OCCURRED DURING AN INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PUMP, BLOOD , SALINE