MAUDE Adverse Event Report: E-Z-EM, INC. PROTOCO2L INSUFFLATION SYSTEM; INSUFFLATOR, AUTOMATIC CARBON DIOXIDE

Catalog Number 6400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Reaction (2414)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, a digestive organ surgeon reported the following info.On an unspecified date in (b)(6) 2013, a pt (no age and gender provided) who had a history of cancer around the appendix that was extirpated (surgically removed) underwent a ct colonography to check for relapse and metastasis.No additional medical history, concomitant illnesses and medications were provided.A protoco2l insufflator catalog number 6400 serial number (b)(4) was used for the ct colonography study.Pt administration set (b)(4) was also used for the procedure.During co2 insufflation of the colon, co2 unexpectedly went up to the small intestine and the pt was about to experience a cardiac arrest.A diagnosis of suspected vagal reaction was provided.No additional info was provided by the reporter.The insufflator system is still in use.Additional info was received by bracco on (b)(6) 2014 and incorporated into bracco's initial report.The pt was a (b)(6) female.Pt history included a resection for pericecal cancer on an unspecified date.The pt refused endoscopy as follow up to check for reoccurrence or metastasis.Ct colonography was therefore performed.The day before the ct colonography she was administered laxoberon and two florsenid (senoside) tablets.On the day of the ct colonography, she was administered niflec, gastrografin 100 (diatrizoate sodium) and a buscopan (hyoscine butylbromide) injection.A bracco pt vc administration set (catalogue number 6470, lot number 50651586, expiration date 02/28/2015) was placed and co2 insufflation was started.The pressure reached the level of 18 mmhg.Ct colonographic images were taken in the left lateral decubitus position and subsequently in the prone position.When the pt was changed to the supine position her face turned pale with abnormal changes in her respiration (not further specified).Her blood pressure was 60 mmhg and heart rate was in the 30's.Vagal reflex was suspected at this time.The ct colonography was immediately terminated, the administration set disconnected from the protoco2l insufflator, co2 gas was removed and saline infusion was administered.The pt improved without any special treatment and she returned home the same day as the colonography procedure.Based on the pt's history of surgical resection of pericecal cancer and the ct images, it was concluded by the reporter that the insufflated co2 flowed into the small intestine which incidentally caused vagal reflex.It was also concluded that since the co2 insufflation pressure was at a normal level, no malfunction of the device occurred.The protoco2l insufflator system is still in use at the facility and there have been no malfunctions occurred.(b)(4).

Manufacturer Narrative

No malfunction of the protoco2l insufflator was reported by the user facility.No occurrence of over pressure insufflation was reported.It was reported that carbon dioxide (co2) gas which was insufflated into the colon went up into the small intestine.The pt was about to experience cardiac arrest and a diagnosis of suspected vagal reaction was provided.The staff member of the user facility reported the indication for the ct colonography was for determination of reoccurrence or metastasis of pericecal cancer.Bracco has therefore assessed use of the protoco2l with this pt as off-label use of the device.The protoco2l device has redundant pressure relief valves to protect against over pressure.Specifically, an electrical pressure relief valve will open when a pressure of 50 mmhg is reached and sustained for 5 seconds, an audible alarm will sound and the pressure display on the front panel of the device will flash.A second independent fixed mechanical pressure relief valve opens if a pressure of 75 mmhg is reached.Additionally, during initial insufflation, when 4 liters of co2 are delivered, the unit automatically returns to the stop mode.Thereafter, to resume the delivery of co2, the device operator presses the flow stop/run button to dispense an additional 2 liters of co2 and the unit again automatically returns to the stop mode.For the incident reported here, there was no report of malfunction or activation of any of these safety features.Bracco is conducting a quality investigation.Company comments: a (b)(6) female pt with a past medical history of resection for pericecal cancer underwent a ct colonography to check for reoccurrence or metastasis.The day before the ct colonography she was administered laxoberon and two florsenid tablets.On the day of the ct colonography, she was administered niflec, gastrografin 100, and a buscopan injection.When the pt changed to the supine position her face turned pale with abnormal changes in her respiration.Her blood pressure was 60 mmhg and heart rate was in the 30's.Vagal reflex was suspected at this time.The ct colonography was immediately terminated.Saline infusion was administered and the pt improved without any special treatment and returned home the same day.Based on the pt's history of surgical resection of pericecal cancer and the ct images, it was concluded by the reporter that the insufflated co2 flowed into the small intestine which incidentally caused vagal reflex.It was also concluded that since the co2 insufflation pressure was at a normal level, no malfunction of the device occurred.Colonoscopy anesthesia has side effects of bradycardia and hypotension and this could have caused the vagal reflux in this pt.Similarly, the co2 released into the colon could have been a specific trigger that caused the vagal reflux.However, the colon insufflator has not known to cause vagal reflux in pts.

• Brand Name: PROTOCO2L INSUFFLATION SYSTEM
• Type of Device: INSUFFLATOR, AUTOMATIC CARBON DIOXIDE
• Manufacturer (Section D): E-Z-EM, INC.; 532 broadhollow rd; ste 126; melville NY 11747
• Manufacturer (Section G): EZEM; 532 broadhollow rd; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd; bldg h; monroe twp, NJ 08831 ; 8002575181
• MDR Report Key: 3782945
• MDR Text Key: 4439525
• Report Number: 2411512-2014-00001
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• PMA/PMN Number: K030854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6400
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SODIUM AMIDOTRIZOATE), (NI TO NOT CONTINUING); BUSCOPAN (HYOSCINE BUTYLBROMIDE),; PROTOCOL2L VC ADMINISTRATION SET; LAXOBERON (SODIUM PICOSULFATE),; SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS),; (NI TO NOT CONTINUING); (NI TO NOT CONTINUING); FORSENID (SENNOSIDE A+B), (NI TO NOT CONTINUING); NIFLEC (POTASSIUM CHLORIDE, SODIUM BICARBONATE,; (NI TO NOT CONTINUING); GASTROGRAFIN 100 (MEGLUMINE AMIDOTRIZOATE,
• Patient Age: 70 YR