BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR TWO DAY 2ML/HR 12 PK

    MDR report key: 2030169 · Received March 27, 2011

    Report

    Report Number
    6000001-2011-02236
    Event Type
    Malfunction
    Date Received
    March 27, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE EVALUATION REVEALED THE TUBING WAS BROKEN AT THE INSERTION POINT OF THE TUBING AND THE SET CAP. THE ASSIGNABLE CAUSE WAS THAT THE DEVICE WAS DAMAGED DURING SHIPPING. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 WRITER WILL SUBMIT A FOLLOW-UP EMDR TO PROVIDE THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR IN WHICH THE TUBING WAS SEPARATED FROM THE STRESS-MEMBER WHEN THE POUCH WAS OPENED. THERE WAS A BREACH IN THE STERILE FLUID PATHWAY. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR TWO DAY 2ML/HR 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H067

    Patients

    Seq Age Sex Outcome Treatment
    1