BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082327 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03812
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. 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. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) OF BLOOD ADMINISTRATION SET LEAKING. THE NURSE NOTICED LEAKING OF BLOOD DURING A TRANSFUSION: A FEW DROPS OF BLOOD LEAKED BETWEEN THE TUBING AND THE SCREW THREAD. WHEN THE NURSE NOTICED THE LEAKING, THE PATIENT STATED THAT HE HAD MADE THE SAME OBSERVATION DURING HIS PREVIOUS TWO DONATIONS. AT THE TIME HE DIDN'T SAY ANYTHING BECAUSE HE THOUGHT THE LEAKING OF A FEW DROPS WAS NOTHING OF PARTICULAR INTEREST. THE NURSE CHECKED ANOTHER FRESH UNIT OF AND SHE FOUND THE SCREW THREAD RATHER LOSE ON THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1