MAUDE Adverse Event Report: BRACCO INJENEERING EMPOWER CTA; CONTRAST INJECTOR SYSTEM

Device Problem No Apparent Adverse Event (3189)

Patient Problem Extravasation (1842)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

The extravasation feature has been designed to help detect potentially serious extravasation.The extravasation detector accessory(eda) is provided as an auxiliary device feature, which assists users in the detection of a possible extravasation.As with all equipment that monitors a patient's physiological response, it is not intended as a substitute for observation and intervention by a trained healthcare professional.Diligence on the part of the owner/operator is an essential requirement of overall patient safety.The extravasation risk should always be minimized by the hospital following best hospital clinical practices and recommended guidelines displayed in user's guide.When the message "eda enabled out of range" is displayed, like in this case before the injection, the eda patch or cable should be verified as specified in user's guide.Otherwise the extravasation detection feature might not be activated during the injection.The system will be investigated to verify if the extravasation feature was enabled or deactivated during the injection.A follow-up report will be performed.Company comment a (b)(6) year-old female was given 80 ml of unspecified contrast agent with use of empower cta injector system, for ct scan (abdomen / pelvis).Before the injection, the system was intermittently displaying a message "eda out of range" when attaching the eda (extravasation detector accessory) patch to the patient.The contrast agent was administered at 2.5 ml/s when an extravasation occurred.The estimated extravasated volume was of 20-30 cc.The patient was given ice pack on her arm.No additional medical intervention was given and patient recovered.The company will investigate if extravasation detection feature of the machine was activated during the injection.The eda is provided as an auxiliary device feature to the empower cta injector system, which assists users in the detection of a possible extravasation.However, it is not intended as a substitute for observation and intervention by a trained healthcare professional.The extravasation risk should always be minimized by the hospital following best hospital clinical practices and recommended guidelines displayed in user's guide.

Event Description

A (b)(6) year-old female patient, born on (b)(6) 1945, with unknown clinical condition and indication for the ct scan (abdomen/pelvis), was undergoing an injection of cm (volume of 80 ml at 2.5 ml/s), using the empower cta injector system, when an extravasation occurred.The estimated extravasated volume was of 20-30 cc.There was no medical intervention required apart that the techs ice packed the patient's arm.The patient recovered without any damage.Before the injection, the system was intermittently displaying a message "eda (extravasation detector accessory) out of range" when attaching the eda patch to the patient.It is not known if during the injection the eda patch was active and functional.The system will be investigated to verify if the extravasation detection system was activated by the end-user during injection.It seems not to be the case.The reporter did not specify the name of the contrast media drug which was involved in the extravasation.

Manufacturer Narrative

The extravasation feature has been designed to help detect potentially serious extravasation.The extravasation detector accessory(eda) is provided as an auxiliary device feature, which assists users in the detection of a possible extravasation.As with all equipment that monitors a patient's physiological response, it is not intended as a substitute for observation and intervention by a trained healthcare professional.Diligence on the part of the owner/operator is an essential requirement of overall patient safety.The extravasation risk should always be minimized by the hospital following best hospital clinical practices and recommended guidelines displayed in user's guide.When the message "eda enabled out of range" is displayed, like in this case before the injection, the eda patch or cable should be verified as specified in user's guide.Otherwise the extravasation detection feature might not be activated during the injection.The system will be investigated to verify if the extravasation feature was enabled or deactivated during the injection.A follow-up report will be performed.Company comment: a (b)(6) female was given 80 ml of unspecified contrast agent with use of empower cta injector system, for ct scan (abdomen / pelvis).Before the injection, the system was intermittently displaying a message "eda out of range" when attaching the eda (extravasation detector accessory) patch to the patient.The contrast agent was administered at 2.5 ml/s when an extravasation occurred.The estimated extravasated volume was of 20-30 cc.The patient was given ice pack on her arm.No additional medical intervention was given and patient recovered.The company will investigate if extravasation detection feature of the machine was activated during the injection.The eda is provided as an auxiliary device feature to the empower cta injector system, which assists users in the detection of a possible extravasation.However, it is not intended as a substitute for observation and intervention by a trained healthcare professional.The extravasation risk should always be minimized by the hospital following best hospital clinical practices and recommended guidelines displayed in user's guide.On 03-mar-2017: follow-up.The results of quality investigation became available: log file analysis confirmed the absence of eda error and does not confirm that the eda was enabled by user during injection.At the date of the incident, eda was only activated once over 4 injections.Installation date of the system (2007/10 years) demonstrates that the device is largely exceeding the defined lifetime.Out of service lifetime eda module passed all extravasation tests.The end-user reported message "eda out of range" when attaching the patch to the patient.As stated in the manual, the eda functionality was hence inactive at the moment of the injection if the end-user did not correct the cause of the message (eda patch wrongly placed, eda cable mis-connected).The non-detection of the extravasation is hence within specification as eda is inactive and that this was displayed to the user.Moreover eda is provided as an auxiliary feature, which assists users in the detection of a possible extravasation.As with all equipment that monitors a patient's physiological response, it is not intended as a substitute for observation and intervention by a trained healthcare professional.Diligence on the part of the owner/operator is an essential requirement of overall patient safety.Conclusion of the investigation: eda was inactive due to use error and was displayed inactive before/during the procedure which explains the non-detection of extravasation.The device is out of service lifetime.The device is not contributor to the complaint.Company comments: a (b)(6) female was given 80 ml of unspecified contrast agent with use of empower cta injector system, for ct scan (abdomen / pelvis).Before the injection, the system was intermittently displaying a message "eda out of range" when attaching the eda (extravasation detector accessory) patch to the patient.The contrast agent was administered at 2.5 ml/s when an extravasation occurred.The estimated extravasated volume was of 20-30 cc.The patient was given ice pack on her arm.No additional medical intervention was given and patient recovered.Based on quality investigation, the eda was inactive due to use error and was displayed inactive before/during the procedure which explains the non-detection of extravasation.The eda is provided as an auxiliary device feature to the empower cta injector system, which assists users in the detection of a possible extravasation.However, it is not intended as a substitute for observation and intervention by a trained healthcare professional.The extravasation risk should always be minimized by the hospital following best hospital clinical practices and recommended guidelines displayed in user's guide.

Event Description

A (b)(6) female patient, born on (b)(6), with unknown clinical condition and indication for the ct scan (abdomen/pelvis), was undergoing an injection of cm (volume of 80 ml at 2.5 ml/s), using the empower cta injector system, when an extravasation occurred.The estimated extravasated volume was of 20-30 cc.There was no medical intervention required apart that the techs ice packed the patient's arm.The patient recovered without any damage.Before the injection, the system was intermittently displaying a message "eda (extravasation detector accessory) out of range" when attaching the eda patch to the patient.It is not known if during the injection the eda patch was active and functional.The system will be investigated to verify if the extravasation detection system was activated by the end-user during injection.It seems not to be the case.The reporter did not specify the name of the contrast media drug which was involved in the extravasation.On 03-mar-2017: follow-up.Quality investigation report was provided.No further information was provided by the reporter.This case is medically closed.

• Brand Name: EMPOWER CTA
• Type of Device: CONTRAST INJECTOR SYSTEM
• Manufacturer (Section D): BRACCO INJENEERING; avenue de sévelin 46; lausanne, 1004 ; SZ 1004
• Manufacturer Contact: maud giorgi ; avenue de sévelin 46; lausanne, 1004 ; SZ 1004 ; 16217400
• MDR Report Key: 6092537
• MDR Text Key: 59970782
• Report Number: 3004753774-2016-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2016
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR