BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2120928 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07551
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: LEAK CONDITION NOT CONFIRMED. EXAMINATION OF THE COMPANION SAMPLE SHOWED NO SIGNS OF ABNORMALITY FROM THE BLUE WINGED CAP OR THE WHITE LUER THAT COULD HAVE RESULTED IN LEAKAGE. A LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE BLADDER WITH RED COLORED WATER. AFTER PRIME WAS VERIFIED, THE BLUE WINGED CAP WAS SECURELY CLOSED ON THE WHITE LUER, THEN THE DEVICE WAS BEING MONITORED FOR 24 HOURS. AFTER 24 HOURS OF LEAK MONITORING PERIOD, NO SIGNS OF LEAKAGE WERE OBSERVED AT THE CONNECTION OF THE BLUE WINGED CAP AND THE WHITE LUER, OR ANYWHERE ON THE ENTIRE SAMPLE. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT "THREE (3) FOLFUSOR SV2.5 ML/H DEVICES LEAKED AT THE BLUE WINGED CAP, DESPITE THE BLUE WINGED CAPS HAVING BEEN ATTACHED SUFFICIENTLY DURING THE FILLING PROCESS." THERE WAS NO REPORT OF PATIENT INVOLVEMENT, MEDICAL INTERVENTION. IT IS UNKNOWN WITH WHAT THE DEVICE WAS FILLED. NO ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 3 FOR THE FACILITY, AS THE FACILITY REPORTED THREE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09D021

    Patients

    Seq Age Sex Outcome Treatment
    1