BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAR

    MDR report key: 1002632 · Received February 26, 2008

    Report

    Report Number
    2936999-2008-00091
    Event Type
    Death
    Date Received
    February 26, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    MIRANDOLA - DAR
    Product Code
    CAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS IN PROGRESS. ATTEMPTS ARE BEING MADE TO OBTAIN FURTHER INFO AND/OR THE DEVICE FOR FAILURE INVESTIGATION. IF THE DEVICE IS RETURNED AND/OR NEW SIGNIFICANT INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A CONVERSATION IN 2008, A HOSP RESP SUPV REMARKED TO OUR CLINICAL SPECIALIST THAT THERE HAD BEEN A PT DEATH WHERE A DAR STERIVENT FILTER ALONG WITH OTHER UNSPECIFIED EQUIPMENT WAS REPORTEDLY USED. WHEN ASKED TO CLARIFY OR PROVIDE FURTHER DETAILS, THE SUPV STATED THAT THE HOSP HAD CHOSEN NOT TO REPORT THIS AS AN EVENT BECAUSE THEY COULD NOT IDENTIFY THE DAR STERIVENT FILTER AS THE CAUSE. THE RESP SUPV ALSO STATED THEY WOULD NOT BE RETURNING THE FILTER FOR FAILURE INVESTIGATION AND HE COULD NOT MAKE ANY FURTHER COMMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAR STERIVENT FILTER CAH MIRANDOLA - DAR 0709001362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death