BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO PUMP

    MDR report key: 4919902 · Received July 16, 2015

    Report

    Report Number
    3005168196-2015-00694
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    GWG
    PMA / PMN Number
    K132931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2015-00695.

    Additional Manufacturer Narrative · 1

    CORRECTED FROM "NO: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN" TO NO: OTHER - THE HOSPITAL CANNOT LOCATE THE PUMP. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING MICRONEUROSURGERY PROCEDURE USING AN APOLLO SYSTEM PUMP AND APOLLO SYSTEM WAND. DURING THE PROCEDURE, THE TIMER ON THE APOLLO PUMP WOULD TURN OFF AND RESTART. THE PHYSICIAN ALSO NOTICED THAT THE APOLLO WAND BEGAN LEAKING SALINE NEAR THE CONNECTION TO THE APOLLO PUMP. THE PHYSICIAN OPENED A NEW APOLLO WAND AND THE PROCEDURE SUCCESSFULLY CONTINUED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464147 APOLLO PUMP GWG GWG PENUMBRA, INC. F62096

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR