BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2242041 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23728
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING A BURETROL INTRAVENOUS SOLUTION ADMINISTRATION SET IN WHICH THE ROLLER CLAMP WAS SHUT, BUT THE UNKNOWN CRITICAL DRUG (NON ADRENALINE DRUG) WAS STILL DRIPPING INTO THE BURETTE CHAMBER DUE TO THIS EVENT, THE PATIENT'S BLOOD PRESSURE DROPPED DUE TO THE OVER-DILUTED DRUG. THE ROLLER CLAMP WAS TAPED DOWN TO PREVENT FURTHER LEAKAGE DILUTION. THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 UNKNOWN DRUG