MAUDE Adverse Event Report: BRACCO DIAGNOSTIC IMAGING PROTOCOL COLON INSUFFLATOR, MODEL 6400

Model Number 6400

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

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)

Event Date 03/25/2022

Event Type  Injury  

Event Description

This report was received from a healthcare professional as an invalid report due to lack of patient identifiers on (b)(6) 2022.Additional information received from the reporter on 29-mar-2022 and 31-mar-2022.With the receipt of additional information, including patient identifiers this case became valid, all information was incorporated into the initial report.The case describes the occurrence of possible caecum perforation and discomfort abdominal in a (b)(6) outpatient male who underwent a virtual colonoscopy with protocol 6400 colon insufflator on (b)(6) 2022 due to family history of colon cancer.The patient's medical history included prior virtual colonoscopy 6 years earlier, and family history of colon cancer.He had an unspecified "mechanical heart valve" and he was taking warfarin for this reason.No other medical history, including allergies was provided.On (b)(6) 2022, the patient underwent a virtual colonoscopy without sedation with protocol colon insufflator (model number 6400, serial number (b)(4)).The lot number is unknown for the protocol administration set is unknown, this was discarded.The technologist reported that he inflated the protocol with 20 cc air the "gas" was administered and never was greater than 40 to 44, and that during the procedure that patient felt uncomfortable in the upper left abdomen, which the reporter stated, "this is something that is expected." about 20 minutes after the virtual exam, the patient felt uncomfortable, sat up.He told the technician that he couldn't continue with the exam and the technician removed the tube from the patient's rectum.The reporter stated there was nothing unusual happened when he removed the tube, no drainage or anything unusual was noted.He also stated that "all patients complain of being uncomfortable during this procedure." also, the technician did not notice anything unusual when he removed the tube from the patient, the tubing was discarded, the lot number is not available.On (b)(6) 2022, the patient got dressed and after 15 minutes he remained in the waiting room, the patient stated he was feeling better and felt well enough to drive home.On (b)(6) 2022, the reporter stated the radiologist reviewed the virtual colonoscopy results the same day and felt there was a possible perforation.For this reason, the radiologist called the patient and advised the patient to go to emergency room to be evaluated.The reporter stated, the patient drove himself to the emergency room of a local hospital and was admitted to the hospital for possible perforation of the caecum.No other information was available to the reporter, he has no access to medical records for this patient, the patient is at a hospital that is not part of their hospital affiliation.According to the reporter, further follow up is not possible.At the time of this report, according to the reporter, no further information is available for this report and the site does not perform follow up on patients once they leave the outpatient facility.Outcome: unknown.A request was made to the site/facility for the return of the protocol 6400 colon insufflator for quality inspection.On 11-apr-2022, it was confirmed the device was received and is currently pending shipment to the manufacturing site for testing and quality inspection.Additional information is required.(b)(4).Track wise # (b)(4).Company comment: a (b)(6) outpatient male underwent a virtual colonoscopy with protocol 6400 colon insufflator due to family history of colon cancer.He had prior virtual colonoscopy 6 years earlier.During this procedure, they inflated his colon with gas (never greater than 40 to 44).About 20 minutes after starting the virtual colonoscopy, the patient felt uncomfortable in the upper left abdomen and stated that he couldn't continue the procedure.Nothing unusual was observed when the technician removed the tube from his rectum, so the tubing was discarded.The patient got dressed and remained in the waiting room for 15 minutes after which he felt well enough to drive home.That same day, the radiologist reviewed the virtual colonoscopy result and saw a possible perforation.The radiologist called the patient and advised him to go to emergency room.The patient drove himself and he was admitted to a local hospital for possible perforation of the caecum.The reporter stated that he has no further information to provide because they do not perform follow up once the patients leave the outpatient facility.As noted in the product label, abdominal discomfort is expected during insufflation due to distention of the colon.Colonic perforation should be suspected when insufflation pauses at 4 liters.The reason for possible colon perforation noted in this case after virtual colonoscopy cannot be determined at this time.Protocol 6400 has safety features including an alarm and automatic pressure relief at 50 mmhg which was never reached during colon insufflation.The insufflator machine will be tested.

Event Description

This report was received from a healthcare professional as an invalid report due to lack of patient identifiers on (b)(6) 2022.Additional information received from the reporter on 29-mar-2022 and 31-mar-2022.With the receipt of additional information, including patient identifiers this case became valid, all information was incorporated into the initial report.The case describes the occurrence of possible caecum perforation and discomfort abdominal in a 52-year-old outpatient male who underwent a virtual colonoscopy with protocol 6400 colon insufflator on (b)(6) 2022 due to family history of colon cancer.The patient's medical history included prior virtual colonoscopy 6 years earlier, and family history of colon cancer.He had an unspecified "mechanical heart valve" and he was taking warfarin for this reason.No other medical history, including allergies was provided.On (b)(6) 2022, the patient underwent a virtual colonoscopy without sedation with protocol colon insufflator (model number 6400, serial number (b)(6).The lot number is unknown for the protocol administration set is unknown, this was discarded.The technologist reported that he inflated the protocol with 20 cc air the "gas" was administered and never was greater than 40 to 44, and that during the procedure that patient felt uncomfortable in the upper left abdomen, which the reporter stated, "this is something that is expected." about 20 minutes after the virtual exam, the patient felt uncomfortable, sat up.He told the technician that he couldn't continue with the exam and the technician removed the tube from the patient's rectum.The reporter stated there was nothing unusual happened when he removed the tube, no drainage or anything unusual was noted.He also stated that "all patients complain of being uncomfortable during this procedure." also, the technician did not notice anything unusual when he removed the tube from the patient, the tubing was discarded, the lot number is not available.On (b)(6) 2022, the patient got dressed and after 15 minutes he remained in the waiting room, the patient stated he was feeling better and felt well enough to drive home.On (b)(6) 2022, the reporter stated the radiologist reviewed the virtual colonoscopy results the same day and felt there was a possible perforation.For this reason, the radiologist called the patient and advised the patient to go to emergency room to be evaluated.The reporter stated, the patient drove himself to the emergency room of a local hospital and was admitted to the hospital for possible perforation of the caecum.No other information was available to the reporter, he has no access to medical records for this patient, the patient is at a hospital that is not part of their hospital affiliation.According to the reporter, further follow up is not possible.At the time of this report, according to the reporter, no further information is available for this report and the site does not perform follow up on patients once they leave the outpatient facility.Outcome: unknown.A request was made to the site/facility for the return of the protocol 6400 colon insufflator for quality inspection.On (b)(6) 2022, it was confirmed the device was received and is currently pending shipment to the manufacturing site for testing and quality inspection.Follow up information received from the manufacturer on 04-may-2022.On 04-may-2022, bracco drug safety received the manufacturers preliminary investigation findings for service and repairs.It was reported the device was received by the manufacturer for service and repair on 20-apr-2022, the manufacturers preliminary investigation, description of the problems found were: minor sticking of mechanical prv, but unit maintained capability to monitor and relieve pressure per specifications.Device will be returned to service for additional investigation.The device was tested for proper operation and did not perform as expected.Flow at 5.0 l/min.Is 4.7 l/min.The acceptable limits are 4.9 - 5.1 l/min.The mechanical and electronic safety relief valves performed as expected.The final investigation report is pending.Additional information is required.Us-bracco-2022us01223.Us fda mdr mfr report # 2411512-2022-00001.Track wise # (b)(4).Company comment: a 52-year-old outpatient male underwent a virtual colonoscopy with protocol 6400 colon insufflator due to family history of colon cancer.He had prior virtual colonoscopy 6 years earlier.During this procedure, they inflated his colon with gas (never greater than 40 to 44).About 20 minutes after starting the virtual colonoscopy, the patient felt uncomfortable in the upper left abdomen and stated that he couldn't continue the procedure.Nothing unusual was observed when the technician removed the tube from his rectum, so the tubing was discarded.The patient got dressed and remained in the waiting room for 15 minutes after which he felt well enough to drive home.That same day, the radiologist reviewed the virtual colonoscopy result and saw a possible perforation.The radiologist called the patient and advised him to go to emergency room.The patient drove himself and he was admitted to a local hospital for possible perforation of the caecum.The reporter could not get additional information.Preliminary device investigation result, states "the device was tested for proper operation and did not perform as expected.The flow at 5.0 l/min.Is 4.7 l/min.The acceptable limits are 4.9 - 5.1 l/min." abdominal discomfort and colonic perforation could occur during insufflation due to distention of the colon.However, it could not be confirmed if the patient had true colonic perforation.Protocol 6400 has safety features including an alarm and automatic pressure relief at 50 mmhg which was never reached during colon insufflation.

Event Description

This report was received from a healthcare professional as an invalid report due to lack of patient identifiers on 25-mar-2022.Additional information received from the reporter on 29-mar-2022 and 31-mar-2022.With the receipt of additional information, including patient identifiers this case became valid, all information was incorporated into the initial report.The case describes the occurrence of possible caecum perforation and discomfort abdominal in a 52-year-old outpatient male who underwent a virtual colonoscopy with protocol 6400 colon insufflator on (b)(6) 2022 due to family history of colon cancer.The patient's medical history included prior virtual colonoscopy 6 years earlier, and family history of colon cancer.He had an unspecified "mechanical heart valve" and he was taking warfarin for this reason.No other medical history, including allergies was provided.On (b)(6) 2022, the patient underwent a virtual colonoscopy without sedation with protocol colon insufflator (model number 6400, serial number (b)(6)).The lot number is unknown for the protocol administration set is unknown, this was discarded.The technologist reported that he inflated the protocol with 20 cc air the "gas" was administered and never was greater than 40 to 44, and that during the procedure that patient felt uncomfortable in the upper left abdomen, which the reporter stated, "this is something that is expected.".About 20 minutes after the virtual exam, the patient felt uncomfortable, sat up.He told the technician that he couldn't continue with the exam and the technician removed the tube from the patient's rectum.The reporter stated there was nothing unusual happened when he removed the tube, no drainage or anything unusual was noted.He also stated that "all patients complain of being uncomfortable during this procedure." also, the technician did not notice anything unusual when he removed the tube from the patient, the tubing was discarded, the lot number is not available.On (b)(6) 2022, the patient got dressed and after 15 minutes he remained in the waiting room, the patient stated he was feeling better and felt well enough to drive home.On (b)(6) -2022, the reporter stated the radiologist reviewed the virtual colonoscopy results the same day and felt there was a possible perforation.For this reason, the radiologist called the patient and advised the patient to go to emergency room to be evaluated.The reporter stated, the patient drove himself to the emergency room of a local hospital and was admitted to the hospital for possible perforation of the caecum.No other information was available to the reporter, he has no access to medical records for this patient, the patient is at a hospital that is not part of their hospital affiliation.According to the reporter, further follow up is not possible.At the time of this report, according to the reporter, no further information is available for this report and the site does not perform follow up on patients once they leave the outpatient facility.Outcome: unknown.A request was made to the site/facility for the return of the protocol 6400 colon insufflator for quality inspection.On 11-apr-2022, it was confirmed the device was received and is currently pending shipment to the manufacturing site for testing and quality inspection.Follow up information received from the manufacturer on 04-may-2022.On 04-may-2022, bracco drug safety received the manufacturers preliminary investigation findings for service and repairs.It was reported the device was received by the manufacturer for service and repair on 20-apr-2022, the manufacturers preliminary investigation, description of the problems found were: minor sticking of mechanical prv, but unit maintained capability to monitor and relieve pressure per specifications.Device will be returned to service for additional investigation.The device was tested for proper operation and did not perform as expected.Flow at 5.0 l/min.Is 4.7 l/min.The acceptable limits are 4.9 - 5.1 l/min.The mechanical and electronic safety relief valves performed as expected.The final investigation report is pending.Follow up information received from the manufacturer on 14-jun-2022 and 30-jun-2022 the final investigation report: results from the manufacturer: upon receipt of the device for inspection (26-apr-2022), the device was tested by the manufacturer for proper operation.It was reported the mechanical safety relief valves performed as expected, with minor sticking of mechanical valves.The electronic valves performed as expected.All recalibration checks of the device had passing data, the flow was lower than specification, flow 5.0l/ minis 4.7 l/min, the acceptable limits are 4.9-5.1 l/ min.The unit appeared to have been performing as expected with respect to relieving pressure appropriately during the incident.The electronic valves performed as expected and pop off at 50 mmhg and passed pre calibration checks.It was reported the pop off valve activates if pressure exceeded 75 mmhg.The device also performed a self-diagnostic check up at the start and prohibits insufflation if any errors occurred.Annual maintenance is prescribed in the manual and labeling; however, the device has not been previously been returned for preventative maintenance /repair/evaluation.There have been no other complaints reported for this device in 11 years.It was reported the unit appeared to have been performing as expected.The unit/device was evaluated and performed as per specifications and passed all inspections and testing during recalibration.Additional attempts were made to obtain further information for this report, however no further information has been provided, therefore this case is medically closed with the information at hand.(b)(4).Track wise # (b)(4).Company comment: a 52-year-old outpatient male underwent a virtual colonoscopy with protocol 6400 colon insufflator due to family history of colon cancer.He had prior virtual colonoscopy 6 years earlier.During this procedure, they inflated his colon with gas (never greater than 40 to 44).About 20 minutes after starting the virtual colonoscopy, the patient felt uncomfortable in the upper left abdomen and stated that he couldn't continue the procedure.Nothing unusual was observed when the technician removed the tube from his rectum, so the tubing was discarded.The patient got dressed and remained in the waiting room for 15 minutes after which he felt well enough to drive home.That same day, the radiologist reviewed the virtual colonoscopy result and saw a possible perforation.The radiologist called the patient and advised him to go to emergency room.The patient drove himself and he was admitted to a local hospital for possible perforation of the caecum.The reporter could not get additional information.Final device investigation report, showed that the mechanical and safety relief valves performed as expected, with minor sticking of mechanical valves.The unit appeared to have been performing as expected with respect to relieving pressure appropriately during the incident.Abdominal discomfort and colonic perforation could occur during insufflation due to distention of the colon.However, it could not be confirmed if the patient had true colonic perforation.Protocol 6400 has safety features including an alarm and automatic pressure relief at 50 mmhg which was never reached during colon insufflation.(b)(4).Us fda mdr mfr report # 2411512-2022-00001.Track wise # (b)(4).

• Brand Name: PROTOCOL COLON INSUFFLATOR, MODEL 6400
• Type of Device: PROTOCOL COLON INSUFFLATOR, MODEL 6400
• Manufacturer (Section D): BRACCO DIAGNOSTIC IMAGING; 259 prospect plains rd; monroe NJ 08831
• Manufacturer Contact: 259 prospect plains rd; monroe, NJ 08831
• MDR Report Key: 14118074
• MDR Text Key: 293632241
• Report Number: 2411512-2022-00001
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 30815112020126
• UDI-Public: (01)30815112020126(11)100126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PROTOCOL ADMINISTRATION SET 6470 - LOT UNKNOWN.; PROTOCOL ADMINISTRATION SET 6470 - LOT UNKNOWN.; PROTOCOL ADMINISTRATION SET 6470 - LOT UNKNOWN.
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male