BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON ACS 900

    MDR report key: 5774566 · Received July 7, 2016

    Report

    Report Number
    3005619970-2016-00010
    Event Type
    Injury
    Date Received
    July 7, 2016
    Report Date
    June 15, 2016
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT A PATIENT UNDERWENT A 4 HOUR SURGICAL PROCEDURE, DURING WHICH HE WAS WEARING THE FLOWTRON L501M LEG GARMENTS. UPON COMPLETION, STAFF NOTICED THAT THERE WAS REDNESS AND SWELLING IN THE CALF AREA. THEY THEN HAD TO PERFORM A SECOND PROCEDURE, A FASCIOTOMY, TO TREAT WHAT THEY BELIEVE WAS ACUTE COMPARTMENT SYNDROME. IT WAS INDICATED THAT THE FLOWTRON ACS900 PUMP NEVER ALARMED OR GAVE ANY INDICATION THAT SOMETHING WAS WRONG. THE FACILITY HAS ISOLATED THE EQUIPMENT AND WILL BE CONDUCTING THEIR OWN INVESTIGATION. ADDITIONALLY, IT WAS REPORTED THAT THIS IS A BRAND NEW PUMP THAT WAS PUT INTO SERVICE LAST MONTH. THE FACILITY STAFF INFORMED THAT "THE PUMP GIVES A BLOCKED TUBE SET ERROR WHEN IT IS CONNECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429592 FLOWTRON ACS 900 FLOWTRON ACS 900 JOW GETINGE (SUZHOU) CO., LTD. 526000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention