BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPT 2 ROVER-ULTRA (230V)

    MDR report key: 2016411 · Received March 4, 2011

    Report

    Report Number
    1811755-2011-00697
    Event Type
    Death
    Date Received
    March 4, 2011
    Date of Event
    March 29, 2010
    Report Date
    May 26, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANIFOLD USED IN THE PROCEDURE WAS DISCARDED BEFORE AN EVAL COULD BE COMPLETED. THE SERIAL NUMBER OF THE ROVER THAT WAS USED IN THIS PROCEDURE WAS NOT AVAILABLE. THE INVESTIGATION IS ONGOING AND THIS REPORT WILL BE UPDATED WHEN NEW INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFO AS IT WAS REPORTED TO THE MFR. ON (B)(6) 2010, IT WAS REPORTED TO THE COMPANY'S REP THAT DURING AN ANEURYSM PROCEDURE, THE NEPTUNE STOPPED WORKING. IT WAS REPORTED THAT BLOOD STARTED TO POOL (TOTAL VOLUME UNK), SO ALTERNATIVE SUCTION WAS NEEDED. ANOTHER ROVER WAS BROUGHT IN AND THE PROCEDURE WAS COMPLETED. AN ADVERSE EVENT WAS NOT REPORTED AT THE TIME. ATTEMPTS WERE MADE TO COLLECT ADD'L INFO FROM THE ACCOUNT BUT WERE UNSUCCESSFUL AND THE COMPLAINT FILE WAS CLOSED. ON (B)(6) 2011, THE CUSTOMER REPORTED AN ADVERSE EVENT TO THE MFR. IT WAS REPORTED THAT ON (B)(6) 2010, A CEREBRAL ANEURYSM PROCEDURE WAS PERFORMED (PT INFO AND MEDICAL RECORDS HAVE BEEN WITHHELD FROM THE MFR). ACCORDING TO THE EVENT DESCRIPTION, DURING THE PROCEDURE, THE SUCTION ON THE NEPTUNE ALLEGEDLY FAILED DUE TO A CLOGGED MANIFOLD. BLOOD BEGAN TO POOL AT THE SURGICAL SITE AND THE USER TURNED TO ADD'L SUCTION OBTAINED BY ANESTHESIA). THIS SECONDARY SUCTION DEVICE WHICH WAS OBTAINED ALSO BECAME CLOGGED AND IT DID NOT WORK. ANOTHER ROVER WAS BROUGHT IN TO COMPLETE THE PROCEDURE. ACCORDING TO THE CUSTOMER, THE PT SUFFERED A PERMANENT NEUROLOGICAL DEFICIENCY AS A RESULT OF THE BLOOD LOSS (TOTAL VOLUME LOST UNK) FROM THE PROCEDURE. THE PT LATER DIED ON (B)(6) 2010 AFTER A FALL IN REHABILITATION THAT RESULTED IN BLEEDING FROM THE BACK OF THE HEAD. THE CUSTOMER DID NOT REPORT THE INCIDENT TO THE MANUFACTURER BECAUSE THEY WERE NOT AWARE OF THE ADVERSE EVENT UNTIL THE FAMILY OF THE PT BROUGHT A LEGAL CLAIM AGAINST THE HOSPITAL. THE CUSTOMER WOULD NOT DISCLOSE PT RECORDS TO THE MFR. AN INCIDENT REPORT WAS REQUESTED FROM THE ACCOUNT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPT 2 ROVER-ULTRA (230V) AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death