BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON EXCEL / TRIO PUMPS

    MDR report key: 2910190 · Received November 23, 2012

    Report

    Report Number
    3005619970-2012-00009
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 29, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JOW
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION ((B)(4)) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ((B)(4) MANUFACTURER COMPLAINT NUMBER: (B)(4). FOLLOWING A VOLUNTARY MEDWATCH REPORT (REF: (B)(6)), ARJOHUNTLEIGH CONDUCTED A REVIEW OF THE DATA SUPPLIED AND ANY OTHER RELEVANT INFORMATION RELATING TO THE EVENT. INFORMATION FROM THE FACILITY SUGGESTS THAT ONE OF OUR SYSTEMS (INTERMITTENT COMPRESSION DEVICE ¿ FLOWTRON EXCEL) FAILED TO FUNCTION, WHILST IN USE DURING A SURGICAL PROCEDURE. THIS WAS NOTICED BY A STAFF MEMBER IN THE OPERATING ROOM AFTER VIEWING THE DEVICES DISPLAY PANEL, WHEREBY THE DISPLAY WAS SHOWING A ZERO PRESSURE READING. THE FACILITY HAS STATED THAT IT IS UNKNOWN AS TO WHEN THE DEVICE MALFUNCTIONED BUT HAVE CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY INJURIES IN RELATION TO THE LOSS OF THERAPY. WITH THE OPERATION LASTING APPROXIMATELY 8 HOURS, IT IS UNKNOWN AS TO WHEN THE OPERATING ROOM NURSE NOTICED THE SYSTEM WASN¿T FUNCTIONING, HOWEVER, WITH NO INJURIES REPORTED, IT APPEARS THAT THE FACILITY POSSIBLY CAUGHT THE FAILURE EARLY AND TOOK THE NECESSARY PRECAUTIONS (MONITORING THE PATIENT¿S CONDITION AS RECOMMENDED IN OUR IFU (247900US)). WE CANNOT BE CERTAIN OF THE ROOT CAUSE FOR THE FAILURE OF THE DEVICE, AS THE FACILITIES BIO-MED DEPARTMENT FAILED TO ISOLATE THE UNIT AT THE TIME OF THE EVENT. WITH NO DEVICE TO EVALUATE, WE ARE UNABLE TO CONFIRM THE TYPE OF MALFUNCTION. OUR POST MARKET SURVEILLANCE DATA SUGGESTS THAT THIS IS AN ISOLATED INCIDENT IN THE FAILURE OF THE AUDIBLE ALARM THAT WOULD NORMALLY ALERT THE USER IN THE EVENT OF LOW PRESSURE. ANOTHER POSSIBLE REASON FOR WHY THE DEVICES DISPLAY PANEL WAS SHOWING ZERO, MAYBE DUE TO A FAILURE IN THE CONNECTION OF THE GARMENT TUBING TO THE PUMP. AGAIN, THIS WOULD BE REPRESENTATIVE OF AN ISOLATED EVENT. IN THE LAST FIVE YEARS, THERE HAVE BEEN 4 MDRS REPORTED AGAINST THE FLOWTRON EXCEL SYSTEM. MDR - #1000381138-2011-00008, 00033, 00034, 00032. NONE OF THE ABOVE EVENTS RELATED TO A MALFUNCTION OF THE DEVICE AND FAILURE TO ALERT THE USER. BASED ON THE NUMBER OF FLOWTRON EXCEL UNITS DISTRIBUTED INTO THE MARKET, THE NUMBER OF COMPLAINTS FOR THE PREVIOUS YEAR AND CURRENT YTD EQUATE TO 2.1%, OF WHICH 0.1% RELATED TO AN ADVERSE EVENT. IN CONCLUSION, THIS EVENT APPEARS TO BE ISOLATED WITH NO OCCURRENCE OF INJURY.

    Description of Event or Problem · 1

    PER FACILITY-SUBMITTED MDR TO THE FDA (IMPORTER# 2301650000-2012-8015): ¿EVENT DESC: IN THE OPERATING ROOM, A PCD (PRESSURE COMPRESSION DEVICE) MACHINE WAS CONNECTED TO STOCKINGS ON THE PATIENT AT THE START OF SURGERY WITH NO APPARENT PROBLEM-NO MALFUNCTION. HOURS LATER DURING THE PROCEDURE, THE OPERATING ROOM RN WAS WATCHING THE DISPLAY ON THE MACHINE AND NOTICED THAT THE DISPLAY NEVER CHANGED FROM 00 (INDICATING THAT THE STOCKINGS WERE NOT INFLATING). THERE WAS NO ALARM ON THE MACHINE THAT WOULD HAVE ALERTED THE RN OF A MALFUNCTION. THE RN THEN REACHED UNDER THE SURGICAL DRAPES AND FELT THE STOCKINGS FOR SEVERAL MINUTES TO SEE IF THEY WERE INFLATING (VERSUS AN ISSUE WITH THE DISPLAY). HOWEVER, THE STOCKINGS WERE NOT INFLATING. A NEW MACHINE WAS OBTAINED, WHICH DID WORK PROPERLY. IT IS UNKNOWN FOR HOW LONG THE DEVICE WAS NOT WORKING PRIOR TO THE RN¿S DISCOVERY. THE SURGERY WAS 8 HOURS LONG. THERE WAS NO HARM OR INJURY TO THE PATIENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXCEL / TRIO PUMPS JOW GETINGE (SUZHOU) CO. LTD. 247001

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR