BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2061598 · Received April 18, 2011

    Report

    Report Number
    2954761-2011-00015
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A REPORT OF AN UNKNOWN NUMBER OF PATIENTS IN WHOM FLOSEAL WAS USED WITHOUT IRRIGATION. THE DESCRIPTION FROM THE REPORTER STATES THAT HE HAS BEEN USING FLOSEAL FOR THE PAST THREE YEARS. DURING HIS INITIAL USE, HE DID NOT BELIEVE THAT IRRIGATION OF EXCESS MATRIX WAS IMPORTANT. IN HIS EARLY EXPERIENCE HE HAD PATIENTS DEMONSTRATE INFLAMMATION AND FLUID BUILDUP (SEROMA OR KNEE EFFUSION) BOTH OF WHICH COULD RESULT IN A REDUCTION IN THE PATIENT'S RANGE OF MOTION OF THAT JOINT. THESE SYMPTOMS ARE HIGHLY LIKELY RELATED TO THE EXCESS UNINCORPORATED MATRIX BEING LEFT IN THE JOINT. THESE CASES WERE PERFORMED PRIOR TO BAXTER INITIATING FIELD CORRECTIVE ACTIONS ((B)(4)) WHICH INCLUDED ENHANCEMENT OF THE IFU FOR FLOSEAL VHSD, AS WELL AS A CONDUCTING A MASS MAILING TO ALL HOSPITALS ORDERING THE PRODUCT EMPHASIZING THE IMPORTANCE OF THE CORRECT APPLICATION TECHNIQUE AND INDICATION FOR USE OF FLOSEAL. SPECIFICALLY: REINFORCEMENT OF USE ONLY ON ACTIVELY BLEEDING TISSUES AND CLEARLY STATING FLOSEAL IS NOT TO BE USED AS PROPHYLAXIS AGAINST POST OPERATIVE BLEEDING. REINFORCING THE NEED FOR THOROUGH IRRIGATION OF ALL UNINCORPORATED FLOSEAL MATRIX TO AVOID A POTENTIAL INFLAMMATORY REACTION. ACCORDING TO THE REPORTER, ONCE HE INITIATED MORE THOROUGH IRRIGATION OF THE WOUND TO REMOVE THE EXCESS MATRIX, THESE SYMPTOMS STOPPED OCCURRING, DEMONSTRATING THAT WITH PROPER IRRIGATION, THERE IS NO PATIENT RISK. THE REPORTER'S DESCRIPTION OF HIS APPLICATION TECHNIQUE WAS STILL NOT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE AS HE APPLIED THE PRODUCT ONTO NON-ACTIVELY BLEEDING TISSUES. AS THE TOURNIQUET WAS INFLATED AT THE TIME OF PRODUCT APPLICATION, THERE WOULD BE A DELAY IN CONTACT WITH THE PATIENT'S BLOOD BUT NO RISK OF ENTRY INTO THE VASCULAR SYSTEM. AS THE REPORTER HAS STOPPED USING FLOSEAL IN HIS PRACTICE, NO RETRAINING IS REQUIRED. NO FURTHER ACTION IS REQUIRED. (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTING SURGEON STATED THAT HE INITIALLY THOUGHT THAT IRRIGATION WAS NOT IMPORTANT; HE HAD USED FLOSEAL IN TOTAL KNEE ARTHROPLASTY PROCEDURES WITHOUT ATTENTION TO IRRIGATION. THROUGHOUT HIS 3 YEAR EXPERIENCE, THE SURGEON SAW A VARIETY OF ISSUES (SUCH AS SEROMAS, KNEE EFFUSIONS OR INFLAMMATORY REACTIONS OF THE KNEE AND EVEN REDUCTION OF RANGE OF MOTION), WHICH LEAD HIM TO BECOME MORE THOROUGH IN HIS IRRIGATION TECHNIQUES. THE SURGEON DESCRIBED HIS APPLICATION TECHNIQUE AS FOLLOWS: RELEASE THE TOURNIQUET WITH THE TEMPORARY INSERT IN POSITION. TREAT ALL VISIBLY BLEEDING SITES WITH BIPOLAR CAUTERY (NOT FLOSEAL). RE-INFLATE THE TOURNIQUET; INJECT THE SOFT TISSUES WITH EPINEPHRINE. APPLY FLOSEAL (NO DESCRIPTION OF ACTIVE BLEEDING, NO DESCRIPTION OF APPROXIMATION OR DESCRIPTION OF LENGTH OF TIME FLOSEAL GIVEN TO WORK). REPLACE TEMPORARY WITH POLYETHYLENE INSERT, TOURNIQUET RELEASED, IRRIGATION DESCRIBED AS "LAVAGE" OR "GENTLE, POURING WATER FROM A BASIN MULTIPLE TIMES" EACH TIME GETTING FEWER AND FEWER LOOSE GELATIN GRANULES. THE SURGEON HAS STOPPED USING FLOSEAL IN PROCEDURES. THE EXACT NUMBER OF PATIENTS THAT EXPERIENCED INJURIES WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1