MAUDE Adverse Event Report: BRACCO INJENEERING FASTLOAD CTA DUAL SYRINGE PACK W/ SPIKE

Model Number	017355
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bracco injeneering received on june 05, 2018 a user facility medwatch from fda, which contains additional information to those initially reported by the customer to bracco injeneering.This product problem had caused no patient or operator injury as reported by the user to fda.With the new information received on june 05, 2018 from fda, it appears that water leaked on the injector and that the device was shut down for safety reason (as preventive measure).The new information are used to continue the investigation, but no root cause of spike breakage is yet identified.Investigation will continue and a follow-up report will be sent.
Event or Problem Description
On (b)(6) 2018, a healthcare professional (nurse) reported to bracco injeneering a device malfunction with the use of fastload cta syringe pack.The report was forwarded to bracco drug safety on 25-jun-2018.The nurse reported when attempting to load, the fastload cta ct syringe pack on the injector, the dual fill button on the touch screen was pressed and an error message was received: system fault n°234 - an injector hardware fault was detected - re-power injector or call for service.After 3 unsuccessful restarts, a different scanner was used for the study.The operator attempted a few more restarts and tried to remove the syringe in the injector.A puddle of water was noted on the floor at this time.When he inverted the head of the injector, water poured out of the head of the injector, so it was shut down for safety.The cause of pouring was identified as the spike used to load saline into one of the syringes, because it cracked when twisted on the syringe.Defective kits were returned to bracco injeneering for investigation.No patient or operator injury was reported.A quality investigation is ongoing.(b)(4).Corresponding worldwide case id: (b)(4).
Event or Problem Description
On (b)(6) 2018, a healthcare professional (nurse) reported to bracco injeneering a device malfunction with the use of fastload cta syringe pack.The report was forwarded to bracco drug safety on 25-jun-2018.The nurse reported when attempting to load the fastload cta ct syringe pack on the injector, the dual fill button on the touch screen was pressed and an error message was received: system fault n°234 - an injector hardware fault was detected - re-power injector or call for service.After 3 unsuccessful restarts, a different scanner was used for the study.The operator attempted a few more restarts and tried to remove the syringe in the injector.A puddle of water was noted on the floor at this time.When he inverted the head of the injector, water poured out of the head of the injector, so it was shut down for safety.The cause of pouring was identified as the spike used to load saline into one of the syringes, because it cracked when twisted on the syringe.Defective kits were returned to bracco injeneering for investigation.No patient or operator injury was reported.The results of quality investigation became available.Based on the current investigation, the risk of electrical shock for the operator or patient has been excluded because the design of the device already prevents such event.Therefore, such event is not able to cause patient or operator injury.An action to determine the root cause of the defective spike is currently in progress with the supplier.Most recent follow-up information incorporated above includes: on 3-sep-2018: investigation results provided and added to the case.This case is medically closed.(b)(4).
Additional Manufacturer Narrative
Bracco injeneering received on (b)(6) 2018 a user facility medwatch from fda, which contains additional information to those initially reported by the customer to bracco injeneering.This product problem had caused no patient or operator injury as reported by the user to fda.With the new information received on june 05, 2018 from fda, it appears that water leaked on the injector and that the device was shut down for safety reason (as preventive measure).The new information are used to continue the investigation, but no root cause of spike breakage is yet identified.Based on the current investigation, the risk of electrical shock for the operator or patient has been excluded because the design of the device already prevents such event.Therefore, such event is not able to cause patient or operator injury.This case is considered as closed.
Event or Problem Description
On 05-jun-2018, a healthcare professional (nurse) reported to bracco injeneering a device malfunction with the use of fastload cta syringe pack.The report was forwarded to bracco drug safety on 25-jun-2018.The nurse reported when attempting to load the fastload cta ct syringe pack on the injector, the dual fill button on the touch screen was pressed and an error message was received: system fault n°234 - an injector hardware fault was detected - re-power injector or call for service.After 3 unsuccessful restarts, a different scanner was used for the study.The operator attempted a few more restarts and tried to remove the syringe in the injector.A puddle of water was noted on the floor at this time.When he inverted the head of the injector, water poured out of the head of the injector, so it was shut down for safety.The cause of pouring was identified as the spike used to load saline into one of the syringes, because it cracked when twisted on the syringe.Defective kits were returned to bracco injeneering for investigation.No patient or operator injury was reported.The results of quality investigation became available.Based on the current investigation, the risk of electrical shock for the operator or patient has been excluded because the design of the device already prevents such event.Therefore, such event is not able to cause patient or operator injury.An action to determine the root cause of the defective spike is currently in progress with the supplier.Most recent follow-up information incorporated above includes: on 3-sep-2018: investigation results provided and added to the case.This case is medically closed.Udi#: (b)(4).Corresponding worldwide case id: (b)(4).
Additional Manufacturer Narrative
Bracco injeneering received on june 05, 2018 a user facility medwatch from fda, which contains additional information to those initially reported by the customer to bracco injeneering.This product problem had caused no patient or operator injury as reported by the user to fda.With the new information received on june 05, 2018 from fda, it appears that water leaked on the injector and that the device was shut down for safety reason (as preventive measure).The new information are used to continue the investigation, but no root cause of spike breakage is yet identified.Investigation will continue and a follow-up report will be sent.Based on the current investigation, the risk of electrical shock for the operator or patient has been excluded because the design of the device already prevents such event.Therefore, such event is not able to cause patient or operator injury.This case is considered as closed.

• Brand Name: FASTLOAD CTA DUAL SYRINGE PACK W/ SPIKE
• Common Device Name: FASTLOAD CTA DUAL SYRINGE PACK W/ SPIKE
• Manufacturer (Section D): BRACCO INJENEERING; avenue de sevelin 46; luasanne, 1004 ; SZ 1004
• MDR Report Key: 7665113
• Report Number: 3004753774-2018-00002
• Device Sequence Number: 2365042
• Product Code: DXT
• UDI-Device Identifier: 17630039300873
• UDI-Public: (01)17630039300873(17)201121(11)171121(10)IAMVO-1711
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K933846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2018
• Report Date (Section F): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/21/2020
• Device Model Number: 017355
• Device Catalogue Number: 017355
• Device Lot Number: IAMVO-1711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 09/03/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1