BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2072971 · Received April 29, 2011

    Report

    Report Number
    6000001-2011-03290
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED AND THE CONDITION WAS CONFIRMED HOWEVER THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A HOSPITAL REPORTER TOLD BAXTER THAT THE TUBING DEVICE CAME APART BELOW THE LOWEST PORT AND BLOOD BACKED UP ONTO THE PATIENT'S GOWN AND BLANKET DURING USE ON (B)(6) 2011. THE REPORTER STATED THAT SHE DID NOT KNOW THE AMOUNT OF BLOOD LOSS IN THE EVENT, BUT THAT NO PERMANENT INJURY WAS REPORTED. THE REPORTER STATED THAT AS SOON AS THE NURSES NOTICED THE INCIDENT, THE TUBING DEVICE WAS CHANGED AND THE PATIENT'S TREATMENT CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10J19081

    Patients

    Seq Age Sex Outcome Treatment
    1