BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1660990 · Received April 14, 2010

    Report

    Report Number
    1063481-2010-00007
    Event Type
    Death
    Date Received
    April 14, 2010
    Report Date
    April 13, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. CRYOLIFE EXPECTS ADD'L INFO REGARDING THE CASE FROM THE FOOD AND DRUG ADMINISTRATION. ANY ADD'L INFO WILL BE PROVIDED IN THE FINAL REPORT. (B) (4).

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, A (B) (6) PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN AORTIC GRAFT. MULTIPLE DEVICES INCLUDING BIOGLUE AND A DACRON AORTIC GRAFT WERE USED DURING SURGERY. THE PATIENT DIED APPROXIMATELY 10 DAYS AFTER SURGERY. THE AUTOPSY REVEALED A FUNGAL MASS IN THE GRAFT LOCATION AND FUNGUS THROUGHOUT THE ORGANS. THE ORGANISM WAS REPORTEDLY IDENTIFIED AS ASPERGILLUS. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THAT BIOGLUE MET ALL SPECIFICATIONS. AN EPIDEMIOLOGICAL INVESTIGATION PERFORMED BY THE HOSPITAL FAILED TO IDENTIFY A CAUSE OF THE DISSEMINATED INFECTION. HOWEVER, THE FINAL REPORT INDICATED THAT FUNGAL ORGANISMS WITHIN THE PATIENT'S LARGE INTESTINES MAY HAVE GAINED ACCESS TO THE CIRCULATORY SYSTEM AND ADHERED TO THE DACRON GRAFT MATERIAL. THE FUNGUS MAY HAVE THEN PROLIFERATED AND EMBOLIZED THROUGH THE SYSTEMIC CIRCULATION LEADING TO DISSEMINATION. THE INVESTIGATION DOES NOT IMPLICATE BIOGLUE AS A POTENTIAL CAUSE OF THE INFECTION. ADDITIONALLY, BIOGLUE IS TERMINALLY STERILIZED WITH GAMMA IRRADIATION. IT IS UNLIKELY THAT BIOGLUE CONTRIBUTED TO THIS EVENT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, AN AORTIC GRAFT WAS IMPLANTED INTO THE (B) (6) PT. BIOGLUE AND OTHER MEDICAL DEVICES WERE ALSO USED DURING THE PROCEDURE. THE PT EXPIRED APPROX 10 DAYS FOLLOWING THE PROCEDURE. AN AUTOPSY WAS PERFORMED WHICH REVEALED A FUNGAL MASS IN THE GRAFT AREA AND THE PRESENCE OF FUNGUS THROUGHOUT THE PT'S ORGANS. THE FUNGUS WAS REPORTEDLY IDENTIFIED AS ASPERGILLUS SP. NO ADD'L INFO WS PROVIDED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP)'S CAREGIVER (CG) CONTACTED BAXTER TO REPORT LEAKING ON THE CASSETTE FROM THE WHERE THE PLUNGER IS, ON THE FILL LINE DURING PRIMING. THE CG ADDED THAT THE LEAKING STOPS WHEN SHE PUSHED DOWN ON THE PLUNGER. THE EVENT DATE WAS UNKNOWN. NO INJURY WAS REPORTED DURING THE INITIAL REPORT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(6) 2010 REGARDING THE LEAK, IT WAS REVEALED THAT THEY HAD THE HP AND CG COME TO THE CLINIC AND WERE OBSERVED PERFORMING SETUP FOR THERAPY. PER NURSE, THEY WERE PERFORMING THE SETUP APPROPRIATELY, AND ADDED THAT IT WAS JUST SOME OVER-PRIMING AND THAT WAS IT. THIS WRITER EXPLAINED THE NURSE THE NEED FOR INVESTIGATION OF OVER-PRIMING. THE NURSE UNDERSTOOD, AND REPORTED THAT HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. THE NURSE DID NOT HAVE INFORMATION ABOUT THE SAMPLE AVAILABILITY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT SURVEILLANCE CONTACTED THE CG ON (B)(6) 2010 REGARDING THE CASSETTE LEAKS. THE CG EXPLAINED THAT DURING PRIMING ONLY, THE FLUID OVERFLOWED FROM THE TOP OF THE LINE, AND THE CG ADDED THAT SHE JUST CLAMPS THE LINE TO STOP IT. PER CG, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT, AND THAT SHE DID NOT NOTICE ANY DEFECTS ON THE CASSETTES EITHER. THE CG STATED THAT SHE HAS ALREADY DISCUSSED THE ISSUE WITH THE NURSE. THIS WRITER ADVISED THE CG TO CONTACT THE NURSE FOR ADVICE ON APPROPRIATELY SETTING-UP THE HEIGHT OF THE TUBING AND HC CYCLER TO AVOID THE "OVERFLOWING" DURING PRIMING. THE CG AGREED. THE CG STATED THAT SHE HAS ALREADY DISCARDED THE CASSETTES. PER CG, HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3515-5-US 09MUV019

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death AORTIC GRAFT| OTHER MEDICAL DEVICES