BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSPRAY CE OPTIMIZED DESIGN

    MDR report key: 1941192 · Received December 29, 2010

    Report

    Report Number
    2954761-2010-00048
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    August 27, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    FMF
    PMA / PMN Number
    K050495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS AN ABNORMAL USE OF SEVERAL MEDICAL DEVICE(S). SURGEON AND OR STAFF USED THE MEDICAL DEVICES WITHOUT READING THE INSTRUCTIONS FOR USE AND WITHOUT BEING PROPERLY INSTRUCTED ABOUT THE ASSEMBLING AND USE OF A LAPAROSCOPIC SPRAY DEVICE. FOLLOWING MAJOR ERRORS HAVE OCCURRED: SURGEON USING THE SYSTEM DESPITE OR STAFF NOT INSTRUCTED EASYSPRAY IS NOT INTENDED FOR USE IN LAPAROSCOPIC PROCEDURES (IFU EASYSPRAY: "THE EASYSPRAY DEVICE IS TO BE USED ONLY WITH SPRAY SETS SPECIFIED FOR USE WITH THIS PRESSURE REGULATOR. ONLY QUALIFIED OPERATING ROOM PERSONNEL SHOULD OPERATE THE DEVICE, HAVING FIRST READ THIS MANUAL CAREFULLY", AND FURTHER "ONLY SPRAY SETS DESIGNATED FOR USE WITH THE EASYSPRAY DEVICE SHOULD BE USED." CAUTION: "SPRAYING INTO ENCLOSED BODY CAVITIES REQUIRES APPROPRIATE SAFETY MEASURES TO MAKE SURE THAT THE ABOVE MENTIONED RISKS WILL BE AVOIDED.") DUPLOCATH MIS 35 IS NOT A DEVICE FOR GAS-DRIVEN APPLICATION OF THE FIBRIN SEALANT. THE PRESSURE LINE OF THE SPRAY SET HAS TO BE CONNECTED TO THE SPRAY HEAD OF A DUPLOJECT SYSTEM AND NOT TO THE LAPAROSCOPIC PORT SYSTEM. MEDICAL AIR SHOULD NOT BE USED IN LAPAROSCOPIC PROCEDURES, INSTEAD CO2 IS RECOMMENDED. THE PNEUMOTHORAX IS RELATED TO MULTIPLE ABNORMAL USES OF TISSEEL APPLICATION DEVICES WITHOUT KNOWLEDGE OF OPERATING THE USED DEVICES AND IGNORING THE FACT THAT OR PERSONNEL IS NOT BEING INSTRUCTED ON THE CORRECT USE OF THE GAS DRIVEN DEVICES AND APPLICATORS FOR TISSEEL. THIS CHAIN OF EVENTS THAT POTENTIALLY CAUSED THE PNEUMOTHORAX IS BEYOND THE CONTROL OF THE MANUFACTURER. THERE ARE NO FLAWS OR INCONSISTENCIES IN THE DESIGN AND LABELING OF THESE MEDICAL DEVICES. A COMPREHENSIVE DOCUMENTED TRAINING OF THE SURGEON AND THE OR STAFF ON THE CORRECT USE OF FOLLOWING DEVICES IS MANDATED: EASYSPRAY AND SPRAY SET, DUPLOSPRAY MIS REGULATOR, DUPLOSPRAY MIS APPLICATOR, AND DUPLOCATH MIS 35. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RETRAINING OF THE SURGEON AND OR STAFF.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM BAXTER SALES REPRESENTATIVE ON (B)(4) 2011: THE BAXTER (B)(4) SALES REPRESENTATIVE ADVISED THE REPORTER THAT THE DEVICES THAT WERE USED DURING THE REPORTED CASE WERE NOT USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFUS). THE DEVICES WERE NOT FAULTY IN ANYWAY AND THE STAFF REQUIRES IN-SERVICING REGARDING ALL OF THE DEVICES. AT THIS TIME THE DEVICES ARE UNDERGOING APPROVAL AT THE HOSPITAL SITE FOR USE. AS IT IS UNKNOWN WHEN THE DEVICES WILL OBTAIN HOSPITAL APPROVAL, BAXTER IS UNABLE TO SCHEDULE THE IN-SERVICING AT THIS TIME. ONCE THE DEVICES HAVE GONE THROUGH THE APPROVAL PROCESS THE SITE HAS BEEN ADVISED TO CALL BAXTER FOR IN-SERVICING. NO FURTHER INVESTIGATION IS REQUIRED. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    DURING A CLOSED PROCEDURE A DUPLOCATH 35MIS WAS INCORRECTLY USED IN COMBINATION WITH THE EASYSPRAY MACHINE. DUE TO MEDICAL AIR RATHER THAN CO2 BEING INTRODUCED INTO THE ABDOMINAL CAVITY THE PATIENT SUSTAINED A PNUEMOTHORAX. ADDITIONAL INFORMATION RECEIVED FROM THE BAXTER AUSTRALIA ON 15-DEC-2010: OPERATION: LAPAROSCOPIC PARTIAL RETROPERITONEAL NEPHRECTOMY. DATE: (B)(6) 2010. PATIENT BLEEDING. SURGEON REQUESTED LAPAROSCOPIC TISSEEL APPLICATOR. SURGEON INFORMED THAT POW DOES NOT HAVE IT. SURGEON REQUESTED TO BORROW DUPLOCATH 35 M.I.S FROM PRIVATE. INFORMED SURGEON NURSING STAFF NOT AWARE OF HOW TO USE PRODUCT. SURGEON CONNECTED TISSEEL TO DUPLOCATH. UNDER INSTRUCTION FROM THE SURGEON, NURSES BROUGHT IN EASYSPRAY CONSOLE. SURGEON CONFUSING EASYSPRAY CONSOLE WITH DUPLOSPRAY CONSOLE. SURGEON CONNECTED EASYSPRAY TUBING TO LAPAROSCOPIC PORT. EASY SPRAY CONSOLE TURNED ON, TOOL AIR INTRODUCED INTO PERITONEUM. PATIENT SUSTAINED PNEUMOTHORAX AS RESULT OF UNCONTROLLED AIR ENTRY. DUPLOCATH 35 MIS USED IN PROCEDURE; THIS WAS ACCEPTABLE PRACTICE, HOWEVER IN ADDITION TO THIS DEVICE BEING USED THE NURSING STAFF INCORRECTLY ATTACHED THE LUER LOCK THAT NORMALLY IS ATTACHED TO THE SPRAYHEAD ATTACHMENT OF THE TISSEEL VHSD. THIS WAS THEN ATTACHED TO THE TROCAR/PORT AS A RESULT THE EASYSPRAY MACHINE WAS TURNED ON AND THE PATIENT RECEIVED MEDICAL AIR. THE CONCERN WITH THIS IS THAT THIS WAS A LAPAROSCOPIC PROCEDURE AND MEDICAL AIR SHOULD NOT HAVE BEEN INTRODUCED INTO THE PERITONEUM CAVITY. PATIENT WAS HOSPITALIZED, BUT NOT DUE TO EVENT. NO ADDITIONAL INFORMATION WILL BE REQUESTED FROM THE REPORTER, SINCE THE REPORTER HAS REFUSED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSPRAY CE OPTIMIZED DESIGN SYRINGE, PISTON FMF BAXTER HEALTHCARE - VIENNA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other