BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUA SEAL ATS COMBO

    MDR report key: 128739 · Received October 29, 1997

    Report

    Report Number
    9611018-1997-00014
    Event Type
    Death
    Date Received
    October 29, 1997
    Report Date
    September 29, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP CONTACT WITH THE CUSTOMER FOUND THAT THE DR FELT THERE WAS NO REASON TO SUSPECT THE DEVICE HAD ANYTHING TO DO WITH THE DISSEMINATED INTRAVASCULAR COAGULATION AND THE REPORTED PT DEATH. THE DR WAS ONLY INQUIRING IF SHERWOOD KNEW OF ANY ARTICLES DEALING WITH DISSEMINATED INTRAVASCULAR COAGULATION IN ASSOCIATION WITH THE USE OF AUTOTRANSFUSION DEVICES. THE PT WAS SUFFERING FROM METASTATIC CARCINOMA AND A TRAUMATIC SURGERY, EITHER OF WHICH CAN INITIATE DISSEMINATED INTRAVASCULAR COAGULATION. A LITERATURE SEARCH WAS PERFORMED ON BEHALF OF THE DR AND THE INFO WAS FORWARDED TO THE REQUESTING PHYSICIAN. CO IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    DR REPORTS, WHILE HE WAS INFUSING A PT WITH THE PT'S BLOOD AS WELL AD DONOR BLOOD, THE PT WENT INTO DIC AND DIED. NO PRODUCT PROBLEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL ATS COMBO CHEST DRAINAGE UNIT WITH AUTO TRANSFUSION KDQ SHERWOOD MEDICAL INDUSTRIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death BANKED BLOOD