BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 2442927 · Received February 3, 2012

    Report

    Report Number
    2411512-2012-00001
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    November 28, 2011
    Report Date
    February 2, 2012
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FCX
    PMA / PMN Number
    K03085
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENTS: A (B)(6) FEMALE PT UNDERWENT A VIRTUAL COLONOSCOPY FOR UNSPECIFIED SCREENING WHICH UTILIZED A CO2 INSUFFLATOR (PROTOCO2L) AND REPORTEDLY EXPERIENCED PERFORATION DURING THE PROCEDURE DIAGNOSED BY RADIOLOGIST ON X-RAY REVIEW. CONSEQUENTLY, THE PT WAS OBSERVED FOR 3 DAYS IN THE HOSPITAL AND WAS GIVEN AN UNSPECIFIED ANTIBIOTIC, THE OUTCOME WAS NOT REPORTED. THE PT'S MEDICAL HISTORY INCLUDING PRIOR GASTROINTESTINAL PROCEDURES/ INTERVENTIONS WAS NOT PROVIDED. DURING THE PROCEDURE A COLOSTOMY TIP WAS INSERTED INTO THE RECTUM, INTRAVENOUS HYOSCINE BUTYLBROMIDE WAS GIVEN AND INSUFFLATING PRESSURES WERE REPORTEDLY 20-23 MMHG. HOWEVER, IT IS UNCLEAR IF THE COLOSTOMY TIP WAS A (B)(4) MANUFACTURED PRODUCT AND THERE WAS NO INFO PROVIDED ABOUT THE SPECIFIC TYPE OF RECTAL CATHETER USED (E.G. RIGIDITY/DIAMETER). ADDITIONALLY, THERE WAS NO INFO PROVIDED REGARDING THE LIKELY SITE OF THE PERFORATION AS WELL AS THE SCREENING RESULTS. THE RETURNED UNIT TESTING RESULTS FROM (B)(4) AND MANUFACTURER'S INVESTIGATION SHOWED THAT THE UNIT MET SPECIFICATIONS. THERE IS LIMITED INFO PROVIDED TO DETERMINE EXACT ETIOLOGY OF THE PERFORATION. FURTHER INFO IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS ONE OF THREE CASES INVOLVED WITH THE SAME DEVICE AT THE SAME USER FACILITY. (B)(6) 2012: THE USER FACILITY REPORTED: A FEMALE PT UNDERWENT A VIRTUAL COLONOSCOPY USING A THE PROTOCO2L INSUFFLATOR SYSTEM AND EXPERIENCED A "PERFORATION." IT WAS REPORTED TO THE PT WAS OBSERVED (HOSPITALIZED) FOR THREE DAYS AND GIVEN AN UNSPECIFIED INTRAVENOUS ANTIBIOTIC. IT WAS REPORTED THAT THE PTS WERE NEVER "INCONTINENT" BY THE PERFORATIONS; THE RADIOLOGIST OBSERVED THE PERFORATIONS WHILE READING THE X-RAYS. NO OTHER INFO WAS PROVIDED. THIS REPORT IS ASSOCIATED WITH THE FOLLOWING REPORT NUMBERS: 2411512-2012-00002 AND 2411512-2012-00003. (B)(6) 2012: THIS IS ONE OF THREE CASES INVOLVED WITH THE SAME DEVICE AT THE SAME USER FACILITY: THE USER FACILITY STATED THAT THE UNIT'S PRESSURE AT THE OUTLET PORT IS NOT THE SAME PRESSURE AS IS INDICATED ON THE UNIT. THE CUSTOMER REPORTED THAT THE PRESSURE PROBLEM LED TO PERFORATIONS IN THREE PATIENTS. THIS UNIT WAS RECEIVED ON 01/23/2012 BY (B)(4) QUALITY ASSURANCE. THE (B)(4) DEVICE UNIT'S ENGINEER PERFORMED FUNCTIONAL TESTING ON THE RETURNED UNIT ON 01/23/2012, AND PER THE PROTOCOL PRESSURE AND FLOW TEST FORM, THE UNIT'S FLOW RATE WAS FOUND TO BE OPERATING TO SPECIFICATION. THE PRESSURE WAS WITHIN SPECIFICATION. IN ADDITION, THE UNIT'S PRESSURE RELIEF VALVES (BOTH ELECTRONIC AND MECHANICAL) WERE TESTED AND FOUND TO BE OPERATING TO SPECIFICATION. THE COMPLAINT COULD NOT BE VERIFIED. ON 01/23/2012, THIS UNIT WAS SENT BACK TO THE (B)(4) SUPPLER (B)(4) FOR FURTHER EVALUATION. TESTING WAS PERFORMED BY (B)(4) ON 01/25/2012 AND THE RESULTS ARE AS FOLLOWS: JANUARY 25, 2012: ADDITIONAL INFO WAS RECEIVED FROM THE USER FACILITY AND INCORPORATED INTO (B)(4) INITIAL ITERATION OF THIS REPORT. A (B)(6) FEMALE UNDERWENT A VIRTUAL COLONOSCOPY FOR SCREENING PURPOSES USING A CO2 INSUFFLATOR PUMP ON (B)(6) 2011 BETWEEN 9:30 AM AND 10:00 AM. PT'S MEDICAL HISTORY, SURGICAL HISTORY, AND CONCOMITANT DISEASES WERE NOT REPORTED. THE FACILITY REPORTED THE PROCEDURE AS FOLLOWS: THE COLOSTOMY TIP WAS INSERTED IN THE RECTUM, IF THE PT HAD NO CONTRAINDICATIONS. BUSCOPAN (HYOSCINE BUTYLBROMIDE) IV WAS INJECTED. CO2 WAS INSULATED FIRST IN THE DECUBITUS RIGHT SIDE UP TO AROUND 1 LITER AND THEN IN DECUBITUS LEFT SIDE UNTIL PRESSURE REACHED AROUND 20 MMHG. AS THE PT IS ON HER BACK, THEY TAKE THE FIRST FEW IMAGES WITH A PRESSURE BETWEEN 20 AND 23 MMHG. WHEN THOSE IMAGES ARE DONE, THE TUBING IS TAKEN OUT AND THE PT IS PLACED ON THEIR ABDOMEN AND THEY RESUME INSUFFLATING THE CO2 KEEPING THE PRESSURE BETWEEN 20 AND 23 MMHG. THEY CAPTURE THE IMAGES (ROUGHLY 2 MINUTES) AND TAKE OUT THE INSUFFLATOR TUBINGS. THE DIAGNOSIS OF THE PERFORATION WAS MADE ON THE SAME DAY, WHEN THE RADIOLOGIST READ THE X-RAYS. THE CO2 INSUFFLATION STOPPED AT THE END OF THE PROCEDURE SO IT WAS UNK IF THE VOLUME OF CO2 PAUSED WHEN THE PERFORATION WAS SUSPECTED. IT WAS REPORTED THERE WERE NO SYMPTOMS OF THE PERFORATION. THE LOCATION OF THE PERFORATION WAS UNK. THE PT WAS HOSPITALIZED ON THE SAME DAY ((B)(6) 2011) FOR APPROXIMATELY 3 DAYS. UNSPECIFIED IV ANTIBIOTICS WERE GIVEN. THE FACILITY REPORTED THEY FOLLOW THEIR "USUAL" INSUFFLATION TECHNIQUE. THERE WAS NO POLYPECTOMY OR BIOPSY PERFORMED. THE PT'S CURRENT STATUS WAS NOT REPORTED. ADDITIONAL INFO IS REQUIRED. WORLDWIDE CASE ID: (B)(4). THE CUSTOMER'S COMPLAINT OF PRESSURE PROBLEMS COULD NOT BE VERIFIED. THE FLOW AND PRESSURE WERE PERIODICALLY ADJUSTED, AND THE UNIT WAS MONITORED FOR ANY INCONSISTENCY IN THE SET PRESSURE DURING MULTIPLE TESTING (SIC). THE UNIT PERFORMED AS EXPECTED AND MET ALL REQUIRED SPECIFICATIONS OUTLINED PER PROCEDURE. ON 01/11/2012, (B)(4) REQUESTED ADDITIONAL INFO. THE SITE WAS VISITED ON 01/19/2012 BY A (B)(4) IMAGING REPRESENTATIVE AND THE SITE WAS WORKING ON THE RESPONSES. ON 01/25/2012, THE FACILITY PROVIDED SOME OF THE ANSWERS TO THE QUESTIONS AND THIS INFO IS INCLUDED I THE DESCRIPTION OF EVENTS. ON (B)(6) 2010, THE SAME USER FACILITY REPORTED MICROPERFORATIONS IN FOUR PTS WITH THIS SAME UNIT (SERIAL #(B)(4)). THE PT EXPERIENCED SLIGHT PAIN, BUT WERE OTHERWISE FINE. THE PTS WERE NOT SENT TO THE EMERGENCY ROOM AND THEY RECOVERED. THE UNIT HAS AN ELECTRONICALLY CONTROLLED PRESSURE RELIEF VALVE AT 50 MM HG AND AN INDEPENDENT REDUNDANT MECHANICAL PRESSURE RELIEF VALVE SET TO 75 MM HG. DURING INVESTIGATION TESTING, THE UNIT'S ELECTRONIC PRESSURE RELIEF VALUE PERFORMED WITHIN SPECIFICATIONS; HOWEVER, THE MECHANICAL PRESSURE RELIEF VALVE DID NOT MEET SPECIFICATIONS. THE UNIT WAS RECALIBRATED AND RETURNED TO THE SITE. THOSE REPORTS ARE ASSOCIATED WITH THE FOLLOWING MANUFACTURER REPORT NUMBERS: 2411512-2010-000005, 2411512-2010-000006, 2411512-2010-000007, AND 2411512-2010-000008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOCO2L INSUFFLATION SYSTEM INSUFFLATOR, AUTOMATIC CARBON DIOXIDE FOR VIRTUAL COLONOSCOPY FCX E-Z-EM, INC. 6400 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization BUSCOPAN (HYOSCINE BUTYLBROMIDE)