BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2091856 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04154
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: NO FLOW CONDITION NOT CONFIRMED. EXAMINATION OF THE DELIVERY TUBING SHOWED NO EVIDENCE OF BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED CONDITION. THE LUER CAP WAS SUBSEQUENTLY REMOVED, AND FLOW WAS READILY OBSERVED AT THE LUER. FLOW CONTINUED WITHOUT STOPPING UNTIL THE SOLUTION WAS EMPTIED FROM THE BLADDER. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    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 (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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) JAPANESE SV 2.5 INFUSOR DEVICE REPORTEDLY STOPPED DELIVERING DURING PATIENT USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND SALINE. THE ACTUAL SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J018

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL