BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3900333 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20651
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: ADDITIONAL PHONE NUMBER- (B)(6). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED. VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED THAT THERE WAS A HOLE IN THE TUBING. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A RETAINED SAMPLE WAS ALSO EVALUATED. VISUAL INSPECTION OF THE RETAINED SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE SET WAS GRAVITY TESTED AND FUNCTIONAL TESTED WITH AN IN-HOUSE INFUSION PUMP; SIMULATED USE TESTING DID NOT REVEAL ANY ISSUES WITH THE RETAINED DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURETROL IV SOLUTION ADMINISTRATION SET LEAKED. THIS OCCURRED DURING A FLUSHING OF NORMAL SALINE IN DELIVERY TUBING THAT BACKFLOWED WITH BLOOD. THE SET WAS FOUND WITH A FRACTURE IN THE LINE. THE DEVICE WAS BEING USED WITH AN INFUSION PUMP. 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
    376571 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 13L19V227

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE INFUSION PUMP| NORMAL SALINE