BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE SV 2.5 INFUSOR

    MDR report key: 2001174 · Received February 24, 2011

    Report

    Report Number
    6000001-2011-01337
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 8, 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 NARRATIVE: CUT CONDITION CONFIRMED. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE DELIVERY TUBING CUT. EXAMINATION OF THE TUBING FOUND THE CUT TO BE SMOOTH SURFACE CUT. THE ROOT CAUSE COULD NOT BE DETERMINED, BUT IS UNLIKELY TO BE DUE TO A MANUFACTURING PROCESS STEP. A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE TUBING OF ONE (1) JAPANESE SV 2.5 INFUSOR WAS OBSERVED CUT DURING PATIENT USE AT THE HOSPITAL. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE SV 2.5 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C084

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE| 5-FLUOROURACIL