BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2, 12 PACK

    MDR report key: 2070031 · Received April 26, 2011

    Report

    Report Number
    6000001-2011-03192
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 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). 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 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

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK CONDITION CONFIRMED. VISUAL EXAMINATION OF THE UNIT FOUND A CUT ON THE DELIVERY TUBING. A LEAK TEST CONFIRMED LEAKAGE AT THE CUT MARK. THE ROOT CAUSE OF THE CUT COULD NOT BE DETERMINED. NO OTHER CAUSE OF LEAK WAS FOUND ON THE UNIT. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF ONE (1) INFUSOR SV 2 THAT WAS REPORTED TO HAVE LEAKED DURING PATIENT USE. ACCORDING TO THE REPORT, THE DEVICE LEAKED FROM THE TUBING AFTER A PROTECTIVE BAG SURROUNDING IT HAD BEEN CUT. THE DEVICE WAS FILLED WITH 92ML OF 5-FLUOROURACIL IN SALINE. THERE WAS 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 INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M096

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL