BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 3170486 · Received June 14, 2013

    Report

    Report Number
    2032282-2013-00059
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    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). DUE TO THE LACK OF INFORMATION, THE CASE IS CURRENTLY NOT ASSESSABLE AND IT IS BEING CONSERVATIVELY REPORTED. BAXTER (B)(4) IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION FROM THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CASE INFORMATION WAS RECEIVED FROM BAXTER (B)(4) ON (B)(4) 2013 AND THE CASE WAS RE-ASSESSED. IT HAS BEEN DETERMINED THAT THE EVENT IS NOT RELATED TO THE USE OF FLOSEAL. BAXTER FOLLOW-UP MEDICAL ASSESSMENT: THE CLINICAL INVESTIGATION REVEALED A SEVERE ACUTE RENAL FAILURE ON THE GROUNDS OF A PREEXISTENT CHRONIC RENAL DISEASE (PREEXISTENT RENAL CALCULI IN BOTH KIDNEYS) AND SIGNIFICANT INTRAOPERATIVE BLOOD LOSS DURING A RIGHT LIVER RESECTION FOR A LARGE (10X15CM) INTRA-HEPATIC HEMANGIOMA. THE ACUTE RENAL FAILURE OCCURRED GRADUALLY AND AGGRAVATED PROGRESSIVELY DURING THE IMMEDIATE POSTOPERATIVE PERIOD WITH TERMINAL RENAL FAILURE AND DEATH ON POSTOPERATIVE DAY 7. THE EVENT HAS A TIME TO DEVICE USE THAT MAKES A CAUSAL RELATIONSHIP IMPOSSIBLE. THERE IS NO IMMEDIATE TEMPORAL AND ANATOMICAL RELATIONSHIP WITH THE APPLICATION OF FLOSEAL (I.E. AN INADVERTENT INTRAVASCULAR APPLICATION TO A HEPATIC VEIN WOULD HAVE CAUSE AN IMMEDIATE PULMONARY EMBOLISM, AND NOT A DELAYED RENAL FAILURE; A POTENTIAL EMBOLISM CANNOT REACH THE RENAL VASCULAR SYSTEM). THE PRE-EXISTENT DISEASE OF THE KIDNEY AND THE EXTENSIVE HEMANGIOMA RESECTED WITH CONSIDERABLE BLOOD LOSS PROVIDE CLINICALLY PLAUSIBLE EXPLANATIONS OF THE FATAL OUTCOME. THE EVENT IS NOT RELATED TO THE INTRAOPERATIVE, CORRECT USE OF FLOSEAL. AFFILIATE OF JOHNSON & JOHNSON (ETHICON) WAS NOTIFIED OF THE CASE AS IT INVOLVED SURIGICEL NUKNIT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO BAXTER (B)(4) THAT ON (B)(6) 2013 THAT ONE OF HIS MALE PATIENT (AGE NOT KNOWN) DIED WHILE ON TREATMENT WITH FLOSEAL. GENDER: MALE. CASE TYPE: SPONTANEOUS. SERIOUS CRITERIA: PATIENT DIED. CAUSE OF DEATH: UNKNOWN. CONCOMITANT MEDICATION: SURGICAL NEWKNIT. AUTOPSY PERFORMED: UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 FROM BAXTER (B)(4): PATIENT INITIALS: (B)(6); AGE: (B)(6); WEIGHT: (B)(6). PATIENT'S MEDICAL HISTORY: PATIENT HAD RENAL CALCULI IN BOTH THE KIDNEYS. RIGHT LOBE HEMANGIOMA (15/10CM). BLOOD PRESSURE WAS NORMAL. PATIENT WAS NOT DIABETIC. HIGH FREQUENCY OF URINATION AND BURNING SENSATION. CONCOMITANT MEDICATIONS USED: DURING SURGERY ISOFLURANE FOR ANESTHESIA AND SURGICAL NUKNIT. POSTOPERATIVE - TAGNUM (SEFOPARAZONE + SALBACTUM) I.V.; TRIMADOL I.V., PANTOPRAZOLE I.V., DYNAPAR I.V.). PATIENT UNDERWENT HEPATECTOMY (RT.) SURGERY. DIAGNOSIS: RT. HEPATIC HEMANGIOMA BILATERAL, RENAL CALCULI; INDICATION: RT. HEPATECTOMY. SURGICAL PROCEDURE: RT. LIVER HEPATIC RESECTION. FLOSEAL APPLICATION SITE: LIVER PARENCHYMA AS IT WAS BLEEDING EXCESSIVELY. INDICATION FOR USE OF FLOSEAL: BLEEDING. VOLUME: 5ML; TECHNIQUE: DIRECT APPLICATION OVER THE LIVER PARENCHYMA AND IMMEDIATELY KEPT WET GAUGE FOR 3-5 MINUTES AND IRRIGATE GENTLY. DATE OF FLOSEAL APPLICATION: (B)(6) 2013. LOT #: NEED TO CHECK WITH PURCHASE MANAGER. WAS FLOSEAL APPLIED IN THE PRESENCE OF ACTIVE BLEEDING? YES. HAS FLOSEAL BEEN APPLIED INTRAVASCULARLY? NO. DATE OF FIRST SIGNS/SYMPTOMS OF AE: (B)(6) 2013. WHAT WAS THE TEMPORAL RELATIONSHIP OF THE DEATH TO THE TIME POINT OF FLOSEAL APPLICATION? 6 DAYS GAP IN BETWEEN APPLICATION OF FLOSEAL AND PATIENT'S DEATH. PLEASE DESCRIBE SYMPTOMS THAT PRECLUDED THE DEATH OF THE PATIENT: POST OPERATIVE THE BILIRUBIN LEVEL OF PATIENT WAS HIGH (10MG/DL). PATIENT'S RENAL WAS COMPROMISED. URINE OUTPUT WAS DRASTICALLY DECREASED DAY BY DAY. ADDITIONAL INFORMATION: DAY 3: PATIENT RENAL FUNCTION DECREASED. DOCTOR STOP DYNAPAR, CONTINUE WITH TRAMADOL AND START LASIX INJECTION (40 MG BD). DAY 4: LOW DOWN THE DOSE OF LASIX INJECTION (20MG BD). DAY 5: LASIX INJECTION STOPPED DUE TO DECREASE IN BLOOD PRESSURE. DAY 6: LASIX INFUSION STARTED (4ML/HR). DAY 7: PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270848 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death