BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON EXCEL/TRIO PUMPS

    MDR report key: 2542821 · Received April 5, 2012

    Report

    Report Number
    3005619970-2012-00004
    Event Type
    Injury
    Date Received
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MFR GETINGE ((B)(4)) CO LTD. (B)(4). BASED ON THE INFO GATHERED IN RELATION TO THIS INCIDENT, IT CAN BE CONFIRMED THAT THE ROOT CAUSE FOR THE INJURY TO THE PT WAS CAUSED BY FAILURE TO CORRECTLY FIT THE GARMENTS WHEN USED IN COMBINATION WITH A HEEL BOOT SYSTEM. THE GARMENT CONNECTOR WAS FITTED INSIDE OF THE HEEL BOOT CAUSING AN INCREASE IN INTERFACE PRESSURE ON THE PT'S SKIN. IT WAS ACKNOWLEDGED BY THE FACILITY THAT USER ERROR CONTRIBUTED TO THE EVENT. WE UNDERSTAND THAT THE PT SUFFERED TWO DEEP TISSUE INJURIES TO BOTH ANKLES, HOWEVER, DUE TO PT CONFIDENTIALITY, WE HAVE BEEN UNABLE TO RECEIVE ANY FURTHER INFO ON THE PT'S CONDITION SINCE THE EVENT. BASED ON OUR: CAUTIONS AND CONTRAINDICATIONS SECTION OF THE IFU (FLOWTRON UNIVERSAL) WE CLEARLY STATE THAT: GARMENTS SHOULD BE POSITIONED IN SUCH A WAY THAT DO NOT CREATE ANY POTENTIAL FOR CONSTANT PRESSURE POINTS ON THE PT'S LIMB. WE THEREFORE CONCLUDE THAT THE INTERFERENCE FIT WITH THE HEEL LIFT BOOT WAS THE CONTRIBUTORY FACTOR THAT LED TO THE INCIDENT. USING THE CORRECT METHOD OF APPLICATION WOULD PREVENT THIS TYPE OF ISSUE OCCURRING. IN REGARDS TO THE GARMENT CONNECTORS POSITION IN RELATION TO THE PT'S LIMB, WE FEEL THAT IN THE LINE WITH OUR RECOMMENDATIONS ((B)(4)), PTS ARE RECOMMENDED NOT TO WALK AROUND WHILST WEARING OUR GARMENTS, THEREFORE WOULD NOT BE ABLE TO CATCH THE CONNECTOR UNDER THEIR FEET. ANOTHER REASON FOR OUR RECOMMENDATION IS THE RISK OF PT FALLING WHILST FITTED TO OUR GARMENTS, AS THIS TYPE OF HAZARD IS POTENTIALLY MORE SERIOUS. A SIMILAR INCIDENT OCCURRED BACK IN 2010 ((B)(4)) WHEREBY INCORRECT FITMENT OF THE GARMENT RESULTED IN TISSUE INJURY TO THE PT'S ANKLE, HOWEVER IN RELATION TO OUR INSTALL BASE (5M PER YEAR), THIS FIGURE IS NEGLIGIBLE. ORIGINAL RISK ANALYSIS DETERMINES THE EVENT TO BE: SEVERITY: 2 AND 3 (2 - MINOR - SHORT TERM INJURY, 3 - MODERATE - LONG TERM INJURY). PROBABILITY OF OCCURRENCE: 3 - POSSIBLE. OVERALL RISK ACCEPTABILITY WAS DETERMINED TO BE: ALARP (AS LOW AS REASONABLY POSSIBLE).

    Description of Event or Problem · 1

    THE US POTENTIAL INCIDENT - THE BULKY TUBING CONNECTOR IS TOO CLOSE TO THE ACTUAL PT'S LEGS, WHEN MOVING LEGS AROUND VERY EASY TO CATCH THIS CONNECTOR SITE UNDER THE HEEL OR FOOT CAUSING A PRESSURE ULCER SITE, ALSO WHEN WEARING HEEL BOOTS UNLESS SPECIFIC TEACHING IS DONE THE TUBING WILL RUN INSIDE THE BOOT AND THE BULKY SITE AGAIN CAUSED PRESSURE ULCER SITES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other