BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIFLO HEAMOSTATIC KIT WITH THROMBIN

    MDR report key: 8385632 · Received March 4, 2019

    Report

    Report Number
    3008478369-2019-00002
    Event Type
    Death
    Date Received
    March 4, 2019
    Report Date
    March 28, 2019
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FERROSAN MEDICAL DEVICES A/S REFERENCE NUMBER: (B)(6) (PATIENT), QN (B)(6) (FETUS). (B)(6) 2019 - FERROSAN MEDICAL DEVICES A/S HAS COMPLETED THE EVALUATION OF THIS INCIDENT. IT HAS NOT BEEN POSSIBLE TO GAIN ANY MORE INFORMATION ON THE EVENT. A PREGNANT WOMAN DIED DURING SURGERY. BOTH THE WOMAN AND THE FETUS DIED. THERE IS ONLY GIVEN INFORMATION THAT THE WOMAN UNDERWENT A SURGERY. THERE IS NO AVAILABLE INFORMATION REGARDING THE FETUS. EVENT DESCRIPTION: "HEPATECTOMY PROCEDURE - PATIENT (FEMALE), 9 MONTHS PREGNANT WITH SEVERE LIVER TUMOR. FATAL TUMOR BED AT THE TOP OF LIVER, CARDIO THORACIC SURGEONS WERE ALSO INVOLVED. SURGIFLO USED DURING HEPATECTOMY, FOLLOWED BY USE OF CELL SAVER. PATIENT DIED DURING PROCEDURE. THIS OCCURRED ABOUT A YEAR AGO HOWEVER ONLY JUST HEARD OF IT." IT IS NOTED THAT A CELL SAVER WAS USED AFTER THE USE OF SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN. AS PER THE INSTRUCTIONS FOR USE OF THE PRODUCT THE FOLLOWING IS NOTED UNDER PRECAUTIONS: "SURGIFLO¿ SHOULD NOT BE USED IN CONJUNCTION WITH AUTOLOGOUS BLOOD SALVAGE CIRCUITS. IT HAS BEEN DEMONSTRATED THAT FRAGMENTS OF COLLAGEN-BASED HAEMOSTATIC AGENTS MAY PASS THROUGH 40 M TRANSFUSION FILTERS OF BLOOD SCAVENGING SYSTEMS." BASED ON THE SPARSE AMOUNT OF INFORMATION IT IS NOT POSSIBLE TO MAKE A FINAL CONCLUSION. SHOULD NEW INFORMATION BECOME AVAILABLE THE CASE WILL BE REOPENED. THE CASE IS CONSIDERED CLOSED. (B)(6) 2019 - INITIAL REPORT: EVENT DESCRIPTION: "HEPATECTOMY PROCEDURE - PATIENT (FEMALE), 9 MONTHS PREGNANT WITH SEVERE LIVER TUMOR. FATAL TUMOR BED AT THE TOP OF LIVER, CARDIO THORACIC SURGEONS WERE ALSO INVOLVED. SURGIFLO USED DURING HEPATECTOMY, FOLLOWED BY USE OF CELL SAVER. PATIENT DIED DURING PROCEDURE. THIS OCCURRED ABOUT A YEAR AGO HOWEVER ONLY JUST HEARD OF IT." THE INFORMATION IS SPARSE AND CLINICAL QUESTIONS HAVE BEEN ASKED. FURTHER ASSESSMENTS WILL BE DONE WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT IS NOTED THAT A CELL SAVER WAS USED AFTER THE USE OF SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN. AS PER THE INSTRUCTIONS FOR USE OF THE PRODUCT THE FOLLOWING IS NOTED UNDER PRECAUTIONS: "SURGIFLO¿ SHOULD NOT BE USED IN CONJUNCTION WITH AUTOLOGOUS BLOOD SALVAGE CIRCUITS. IT HAS BEEN DEMONSTRATED THAT FRAGMENTS OF COLLAGEN-BASED HAEMOSTATIC AGENTS MAY PASS THROUGH 40 M TRANSFUSION FILTERS OF BLOOD SCAVENGING SYSTEMS". AT THE TIME OF REPORTING NO MORE INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    FERROSAN MEDICAL DEVICES A/S REFERENCE NUMBER: QN (B)(4). 03.04.2019. INITIAL REPORT: EVENT DESCRIPTION: "HEPATECTOMY PROCEDURE - PATIENT (FEMALE), (B)(6) PREGNANT WITH SEVERE LIVER TUMOR. FATAL TUMOR BED AT THE TOP OF LIVER, CARDIO THORACIC SURGEONS WERE ALSO INVOLVED. SURGIFLO USED DURING HEPATECTOMY, FOLLOWED BY USE OF CELL SAVER. PATIENT DIED DURING PROCEDURE. THIS OCCURRED ABOUT A YEAR AGO HOWEVER ONLY JUST HEARD OF IT." THE INFORMATION IS SPARSE AND CLINICAL QUESTIONS HAVE BEEN ASKED. FURTHER ASSESSMENTS WILL BE DONE WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT IS NOTED THAT A CELL SAVER WAS USED AFTER THE USE OF SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN. AS PER THE INSTRUCTIONS FOR USE OF THE PRODUCT THE FOLLOWING IS NOTED UNDER PRECAUTIONS: "SURGIFLO¿ SHOULD NOT BE USED IN CONJUNCTION WITH AUTOLOGOUS BLOOD SALVAGE CIRCUITS. IT HAS BEEN DEMONSTRATED THAT FRAGMENTS OF COLLAGEN-BASED HAEMOSTATIC AGENTS MAY PASS THROUGH 40 M TRANSFUSION FILTERS OF BLOOD SCAVENGING SYSTEMS". AT THE TIME OF REPORTING NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: HEPATECTOMY PROCEDURE - PATIENT (FEMALE), 9 MONTHS PREGNANT WITH SEVERE LIVER TUMOR. FATAL TUMOR BED AT THE TOP OF LIVER, CARDIO THORACIC SURGEONS WERE ALSO INVOLVED. SURGIFLO USED DURING HEPATECTOMY, FOLLOWED BY USE OF CELL SAVER. PATIENT DIED DURING PROCEDURE. THIS OCCURRED ABOUT A YEAR AGO HOWEVER ONLY JUST HEARD OF IT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: HEPATECTOMY PROCEDURE - PATIENT (FEMALE), (B)(6) PREGNANT WITH SEVERE LIVER TUMOR. FATAL TUMOR BED AT THE TOP OF LIVER, CARDIO THORACIC SURGEONS WERE ALSO INVOLVED. SURGIFLO USED DURING HEPATECTOMY, FOLLOWED BY USE OF CELL SAVER. PATIENT DIED DURING PROCEDURE. THIS OCCURRED ABOUT A YEAR AGO HOWEVER ONLY JUST HEARD OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179223 SURGIFLO HEAMOSTATIC KIT WITH THROMBIN SURGIFLO WITH THROMBIN LMF FERROSAN MEDICAL DEVICES A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death