BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2, 12 PACK

    MDR report key: 1760176 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01725
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    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.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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF AN INFUSOR SV 2 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B) (4) THAT THE RESERVOIR OF AN INFUSOR SV 2 DEVICE RUPTURED DURING FILLING. THE DEVICE WAS BEING FILLED WITH 5-FLUOROURACIL AND SALINE AT THE TIME OF THE RUPTURE. 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 INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10A016

    Patients

    Seq Age Sex Outcome Treatment
    1