BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3903084 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20911
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 12K052 WAS MANUFACTURED BETWEEN OCTOBER 16, 2013 ¿ OCTOBER 17, 2013. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE BACKFLOW FROM THE FILL PORT WAS NOTED DURING FUNCTIONAL LEAK TESTING. FURTHER EXAMINATION OF THE DEVICE REVEALED THAT THERE WAS A PARTICLE APPROXIMATELY 0.60 MM IN SIZE TRAPPED UNDER THE CHECK BAND. FT-IR SPECTROPHOTOMETER SCANNING REVEALED THAT THE PARTICLE WAS MADE OF POLYPROPYLENE. THE BACKFLOW WAS DETERMINED TO BE DUE TO THE PARTICLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED LARGE VOLUME INFUSOR A LEAK (BACKFLOW) WAS OBSERVED AT THE FILLING PORT. THERE WAS NO PATIENT INVOLVEMENT AS THE CONDITION WAS IDENTIFIED DURING EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380406 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12K052

    Patients

    Seq Age Sex Outcome Treatment
    1