BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2296933 · Received October 14, 2011

    Report

    Report Number
    2954761-2011-00061
    Event Type
    Injury
    Date Received
    October 14, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MANUFACTURING INVESTIGATION: A REVIEW OF THE BATCH RECORD FOR THIS PRODUCT LOT WAS PERFORMED. THE REVIEW OF THE IN PROCESS/RELEASE TESTING AND NONCONFORMANCE DATABASE INDICATES THAT LOT NUMBER HA101245B WAS MANUFACTURED AND RELEASED WITHOUT ANY ABNORMALITIES. BAXTER (B)(4) MADE MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER IN AN EFFORT TO RECEIVE ADDITIONAL INFORMATION PERTAINING TO POSSIBLE ALLERGIC REACTION AND APPLICATION TECHNIQUE. NO RESPONSE WAS RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THE INFORMATION WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION WILL BE SENT. THIS IS THE FIRST COMPLAINT OF THIS NATURE FOR THE REPORTED LOT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE ADDITIONAL INFORMATION REFERS TO A SUDDEN DROP IN BLOOD PRESSURE WITH A REASONABLE TEMPORAL RELATIONSHIP TO THE USE OF FLOSEAL IN A (B)(6) CHILD UNDERGOING A CARDIAC SURGERY PROCEDURE. A BABY'S IMMUNE SYSTEM IS NOT FULLY DEVELOPED UNTIL HE/SHE IS ABOUT SIX MONTHS-OLD. IN THE MEANTIME, PREGNANT MOTHERS PASS IMMUNOGLOBULIN ANTIBODIES FROM THEIR BLOODSTREAM, THROUGH THE PLACENTA, AND TO THE FETUS. THESE ANTIBODIES ARE AN ESSENTIAL PART OF THE FETUS'S IMMUNE SYSTEM AND THUS MAY PERMIT ALLERGIC REACTIONS. IT IS STILL UNCLEAR IF THE DROP IN BLOOD PRESSURE HAS BEEN CAUSED BY AN ALLERGIC REACTION OR A THROMBO-EMBOLIC EVENT DURING THE FLOSEAL APPLICATION. THE ALLERGIC HISTORY OF THE MOTHER AND THE POTENTIAL FOR AN INADVERTENT INTRAVASCULAR APPLICATION ARE TO BE INVESTIGATED. DUE TO THE PLAUSIBLE TEMPORAL RELATIONSHIP (SECONDS AFTER APPLICATION) A CAUSAL RELATIONSHIP CANNOT BE DENIED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND ASSESSMENT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    DR. REPORTED A SHORT FALL OF PRESSURE LEVEL WHILE USING FLOSEAL WAS REPORTED BY THE CUSTOMER. ADDITIONAL INFORMATION RECEIVED: THE DOCTOR USED FLOSEAL IN A (B)(6) BABY ON AN ARTERIAL VALVE REPLACEMENT CASE. AFTER APPLICATION, THERE WAS IMMEDIATE SHORT FALL IN PRESSURE LEVEL. THE INFANT WAS ONLY (B)(6), AND HAS NOT DEVELOPED HIS OWN IMMUNITY. THE QUESTION OF THE MOTHER'S SENSITIVITY WAS NOT DISCUSSED. THE PATIENT WAS OFF CARDIOPULMONARY BYPASS. FLOSEAL WAS APPLIED TO ACTIVE BLEEDING, THE SOURCE WAS NOT IDENTIFIED. BLEEDING WAS CONTROLLED AS BABY WAS CLOSED AND RECOVERED UNEVENTFULLY. THE BLOOD PRESSURE DROPPED WITHIN SECONDS OF FLOSEAL APPLICATION. NO OTHER SYMPTOMS WERE DISCUSSED. FLOSEAL WAS REMOVED IMMEDIATELY, NO OTHER INTERVENTIONS WERE DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD HA101245B

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Other