BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOCO2L INSUFFLATION SYSTEM

    MDR report key: 2442928 · Received February 3, 2012

    Report

    Report Number
    2411512-2012-00002
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    February 2, 2012
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FCX
    PMA / PMN Number
    K030854
    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

    ON (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 PERFORATION IN THREE PTS. THIS UNIT WAS RECEIVED ON JAN 23 2012 BY (B)(4) QUALITY ASSURANCE. THE (B)(4) DEVICE UNIT'S ENGINEER PERFORMED FUNCTIONAL TESTING ON THE RETURNED UNIT ON JAN 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 JAN 23 2012, THIS UNIT WAS SENT BACK TO THE (B)(4) SUPPLIER (B)(4) FOR FURTHER EVALUATION. TESTING WAS PERFORMED BY (B)(4) ON JAN 24 2012 AND THE RESULTS ARE AS FOLLOWS: A (B)(6) MALE PT UNDERWENT A VIRTUAL COLONOSCOPY FOR AN UNSPECIFIED SCREENING WHICH UTILIZED THE CO2 INSUFFLATOR (PROTOCO2L) AND REPORTEDLY EXPERIENCED PERFORATION DURING THE PROCEDURE DIAGNOSED BY RADIOLOGIST ON X-RAY REVIEW. THE PT REPORTEDLY HAD NO PRIOR GASTROINTESTINAL PROCEDURES AS WELL AS NO HISTORY OF DIVERTICULOSIS, TUMORS, INFLAMMATORY BOWEL DISEASE, PREVIOUS PERFORATION ULCERATIVE COLITIS OR INTESTINAL DISEASES. HOWEVER, DESPITE THE REPORTED HISTORY, THE SCREENING RESULTS FORM THE CT COLONOGRAPHY WERE NOT PROVIDED IN ORDER TO COMPLETELY RULE OUT A PRE-EXISTING GASTROINTESTINAL DISORDER. 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 INFORMATION PROVIDED ABOUT THE SPECIFIC TYPE OF RECTAL CATHETER USED (E.G. RIGIDITY/DIAMETER). ADDITIONALLY, THERE WAS NO INFORMATION PROVIDED REGARDING THE LIKELY SITE OF THE PERFORATION. THE RETURNED UNIT TESTING RESULTS FROM (B)(4) AND MANUFACTURER'S INVESTIGATION SHOWED THAT THE UNIT MET SPECIFICATIONS. THERE WAS LIMITED INFORMATION PROVIDED TO DETERMINE THE EXACT ETIOLOGY OF THE PERFORATION. FURTHER INFORMATION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS ONE OF THREE CASES INVOLVED WITH THE SAME DEVICE AT THE SAME USER FACILITY. ON (B)(6) 2012: THE USER FACILITY REPORTED: A MALE PT UNDERWENT A VIRTUAL COLONOSCOPY USING A PROTOCO21 INSUFFLATOR SYSTEM AND EXPERIENCED A "PERFORATION." IT WAS REPORTED THE PT DID NOT REQUIRE HOSPITALIZATION AND RETURNED HOME. IT WAS REPORTED THAT THE PTS WERE NEVER "INCONTINENT" BY THE PERFORATIONS; THE RADIOLOGIST OBSERVED THE PERFORATIONS WHILE READING THE X-RAYS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS ASSOCIATED WITH THE FOLLOWING REPORT NUMBERS: 2411512-2012-00001 AND 2411512-2012-00003. ON (B)(4) 2012: ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY AND INCORPORATED INTO (B)(4)'S INITIAL ITERATION OF THIS REPORT. A HEALTH PROFESSIONAL REPORTED. THE PT WAS A (B)(6) MALE. THE INDICATION FOR THE PROCEDURE WAS "FOR SCREENING PURPOSES." THE PT'S MEDICAL HISTORY AND CONCOMITANT DISEASES WERE REPORTED AS "NOTHING IN PARTICULAR, ACCORDING TO THE PT." THE PT HAD NO HISTORY OF GI TRACT SURGERY OR GASTROINTESTINAL PROCEDURE. THE PT HAS NOT UNDERGONE POLYPECTOMY OR BIOPSY PROCEDURE. THE PT'S MEDICAL HISTORY IS NEGATIVE FOR: DIVERTICULOSIS, TUMORS, INFLAMMATORY BOWEL DISEASE, PREVIOUS PERFORATION ULCERATIVE COLITIS OR INTESTINAL DISEASES. THE PROCEDURE WAS ON (B)(6) 2012 AND THE TIME OF INSUFFLATION WAS BETWEEN 9:00 AND 9:30 AM. THE FACILITY FOLLOWED THEIR USUAL INSUFFLATION PROTOCOL/TECHNIQUE FOR THE PROCEDURE. IF THE PT HAS NO CONTRAINDICATION, THE COLOSTOMY TIP IS INSERTED INTO THE PT'S RECTUM. BUSCOPAN (HYOSCINE BUTYLBROMIDE) IS INTRAVENOUSLY ADMINISTERED. UP TO AROUND 1 LITER OF CO2 IS INSUFFLATED WHILE THE PT IS IN THE DECUBITUS RIGHT SIDE POSITION, AND THEN WITH THE PT IN THE DECUBITUS LEFT SIDE POSITION CONTINUED UNTIL AROUND A PRESSURE OF 20 MMHG IS REACHED. AS THE PT IS ON HIS BACK THE FIRST FEW IMAGES ARE TAKEN WITH A PRESSURE BETWEEN 20 AND 23 MMHG. WHEN THOSE IMAGES ARE DONE THE TUBING IS TAKEN OUT, THE PT PLACED ON HIS ABDOMEN AND INSUFFLATION RESUMED WITH THE CO2 PRESSURE KEPT BETWEEN 20 AND 23 MMHG. IMAGES ARE CAPTURED (ROUGHLY 2 MINUTES) AND THE INSUFFLATOR TUBING TAKEN OUT. THE EXAM WAS PERFORMED AT AROUND 23 MMHG. THE TOTAL AMOUNT OF CO2 ADMINISTERED WAS NOT KNOWN. THE PT HAD NO SYMPTOMS OF PERFORATION. THE DIAGNOSIS OF PERFORATION WAS MADE AT THE RADIOLOGISTS READING OF THE IMAGES, THE SAME DAY ((B)(6) 2012). THE LOCATION OF THE PERFORATION WAS NOT KNOWN. THE RADIOLOGIST CONTACTED THE PT AND DIRECTED THE PT TO HOSPITAL FOR OBSERVATION. THE EMERGENCY ROOM PHYSICIAN WAS CONTACTED BY THE RADIOLOGIST. THE PT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE PERFORATION BY AN EMERGENCY ROOM PHYSICIAN. THE PT LEFT THE HOSPITAL THE SAME DAY, (B)(6) 2012. THE PT'S CURRENT STATUS WAS NOT REPORTED. ADDITIONAL INFORMATION 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 (B)(4) 2012, (B)(4) REQUESTED ADDITIONAL INFORMATION. THE SITE WAS VISITED ON JAN 19 2012 BY A (B)(4) IMAGING REPRESENTATIVE AND THE SITE WAS WORKING ON THE RESPONSES. ON JAN 25 2012, THE FACILITY PROVIDED SOME OF THE ANSWERS TO THE QUESTIONS AND THIS INFORMATION IS INCLUDED IN 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 PTS 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 VALVE 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: 2411512-2010-00005, 2411512-2010-00006, 2411512-2010-00007, AND 2411512-2010-00008.

    Devices

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

    Patients

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