BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR SV 4ML/H

    MDR report key: 1813476 · Received August 24, 2010

    Report

    Report Number
    6000001-2010-02719
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF A FOLFUSOR SV 4 DEVICE WITH A RUPTURED RESERVOIR WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4). THIS DEVICE IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.A TREND REVIEW WAS PERFORMED SHOWING A FAVORABLE TREND YEAR OVER YEAR FOR REPORTED COMPLAINTS OF RUPTURED RESERVOIRS.

    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.PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION POLYPECTOMY SNARE WAS USED DURING A POLYPECTOMY PROCEDURE (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO CAUTERIZE A POLYP, IT WAS DIFFICULT TO CUT WITH THE SNARE, AND THE POLYP BLED MORE THAN WAS EXPECTED. THE COMPLAINANT REPORTED THAT THE GENERATOR (MANUFACTURED BY A COMPETITOR) USED IN THE PROCEDURE WAS NOT OPERATING PROPERLY, BUT FURTHER INFORMATION WAS NOT AVAILABLE. AFTER REMOVAL OF THE POLYP, THE PROCEDURE WAS COMPLETED BY USING HEMOCLIPS TO STOP THE BLEEDING. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A FOLFUSOR SV 4 DEVICE RUPTURED DURING FILLING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR SV 4ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09H059

    Patients

    Seq Age Sex Outcome Treatment
    1