BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSPRAY PRESSURE REGULATOR

    MDR report key: 2940720 · Received June 16, 2006

    Report

    Report Number
    2954761-2006-00017
    Event Type
    Injury
    Date Received
    June 16, 2006
    Date of Event
    May 23, 2006
    Report Date
    June 16, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS SPECIFIC SURGERY FLOSEAL, TISSEEL AND COSEAL HAVE BEEN USED. TISSEEL AND COSEAL WERE APPLIED WITH A GAS-DRIVEN SPRAY DEVICE (EASYSPRAY). THE PNEUMOPERITONEUM IS THE RESULT OF THE SPRAY APPLICATION, AND NOT OF THE VARIETY OF PRODUCTS USED. BOTH THE INSTRUCTIONS FOR USE OF THE SPRAY DEVICE AND THE EASYSPRAY, ARE CAUTIONING AGAINST GAS-DRIVEN APPLICATION IN CLOSED CAVITIES. THIS CAUTION IS NOT INCORPORATED IN THE COSEAL SPRAY SYSTEM. CAUTION: ANY APPLICATION OF PRESSURIZED GAS MAY BE ASSOCIATED WITH A POTENTIAL RISK OF GAS EMPHYSEMA, TISSUE RUPTURE, GAS ENTRAPMENT WITH COMPRESSION, OR AIR EMBOLISM, WHICH MAY BE LIFE THREATENING. BE SURE TO TAKE APPROPRIATE MEASURES TO ADDRESS THESE RISKS BY OBSERVING THE RECOMMENDED MINIMUM SPRAYING DISTANCE (10 CM) AND MAXIMUM PRESSURE (2 BARS). CAUTION: SPRAYING INTO ENCLOSED BODY CAVITIES REQUIRES APPROPRIATE SAFETY MEASURES TO MAKE SURE THAT THE ABOVE MENTIONED RISKS WILL BE AVOIDED. THE PNEUMOPERITONEUM IS THE RESULT OF THE APPLICATION OF BOTH TISSEEL AND COSEAL WITH A SPRAY DEVICE, AND NOT THE RESULT OF THE PRESENCE OF THE PRODUCTS THEMSELVES. THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE PNEUMOPERITONEUM AND THE USE OF FLOSEAL. A RETRAINING OF THE SURGEON IN ACCORDANCE WITH THE ABOVE-MENTIONED CAUTIONS IS REQUIRED. DISCUSSED NEED FOR ALLOWING GAS TO ESCAPE FROM ABDOMEN BEFORE CLOSING. PHYSICIAN AGREED WITH THIS INFORMATION.

    Description of Event or Problem · 1

    FLOSEAL APPLIED TO INFUNDIBULAR LIGAMENTS, THEN PERITONEUM PARTIALLY CLOSED W/PURSESTRING AND COSEAL SPRAYED INTO CUL DE SAC BEFORE TYING DOWN PURSESTRING. TISSEEL SPRAYED ON EDGE OF VAGINAL CUFF (PERITONEUM CLOSED AT THIS TIME). WHEN VAGINAL CUFF CLOSED, NOTED TISSEEL "BUBBLING." SURGEON WONDERED IF THIS WAS NORMAL, BUT FELT IT WAS GAS TRYING TO ESCAPE. AT 18 HRS, POST OP, PT. DISTENDED. FLAT PLATE OF ABDOMEN PERFORMED AND PNEUMOPERITONEUM NOTED, WHICH DR. (B)(6) FELT TO BE RELATED TO COSEAL, AND RETROPERITONEAL AIR ALSO NOTED, WHICH SHE FELT TO BE RELATED TO THE SPRAYING OF TISSEEL. THE FOLLOWING MORNING, UNDER CT GUIDED IMAGING, TWENTY 60CC SYRINGES OF AIR WAS REMOVED FROM ABDOMEN AND RETROPERITONEUM. DATE OF CT PROCEDURE (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSPRAY PRESSURE REGULATOR PRESSURE REGULATOR FMF BAXTER HEALTHCARE CORPORATION 0600012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention