BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, ELASTOMERIC

    MDR report key: 3171758 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15484
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE ISSUE WAS A BURST OF THE RESERVOIR. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE RESERVOIR RUPTURED IN A FOOTED POSITION. THE RESERVOIR WAS ALSO MICROSCOPICALLY EXAMINED FOR ANY ABNORMALITIES THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE RUPTURE. NO ABNORMALITIES WERE DETECTED NEAR THE RUPTURE LINE. THE CAUSE OF THIS CONDITION COULD NOT BE DETERMINED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4).SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TUBING OF A LARGE VOLUME FOLFUSOR HAD DISCONNECTED. THIS OCCURRED AFTER THE DEVICE HAD BEEN CONNECTED TO A PATIENT. THE FOLFUSOR WAS FILLED WITH YONDELIS (TRABECTEDIN). FOLLOWING THE DISCONNECTION, THE FOLFUSOR COULD NOT BE USED AND THE DRUG COULD NOT BE INFUSED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273925 PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A006

    Patients

    Seq Age Sex Outcome Treatment
    1 YONDELIS (TRABECTEDIN)