BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2220587 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20369
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF CRACKED PINK COIL CAP. THE SYSTEMIC ROOT CAUSE OF THIS FAILURE MODE WAS DETERMINED TO BE A MANUFACTURING DEFECT; BOTTLE SHOULDER AND LOW ENGAGEMENT AT THE CAP/BOTTLE INTERFACE CAUSED INTERFERENCE BETWEEN THE CAP AND BOTTLE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS ISSUE HAS BEEN ESCALATED TO CORRECTIVE AND PREVENTATIVE ACTION (CAPA). THE CUSTOMER INITIALLY REPORTED THAT THE ACTUAL SAMPLE WAS NOT AVAILABLE AND ONLY A PHOTOGRAPH WOULD BE RETURNED TO BAXTER FOR EVALUATION. HOWEVER, THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. A PHOTOGRAPH OF THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT A FOLFUSER HAD A CRACKED PINK COIL CAP. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE SAMPLE IS NOT AVAILABLE, ALTHOUGH A PHOTOGRAPH IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11E018

    Patients

    Seq Age Sex Outcome Treatment
    1