MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS/ BRACCO INJENEERING S.A. FASTLOAD CTA DUAL SYRINGE PACK WITH SPIKES; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	017355
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
When attempting to load the fastload cta ct syringe pack on the injector, a 100ml iv saline bag was attached to the provided spike to pierce the bag.After attaching it to the syringe, i placed the contrast on the other provided spike and began to draw the fluids into the syringes.When the "dual fill" button was pressed on the touch screen i received an error: system fault no.234 - an injector hardware fault was detected - re-power injector or call for service.I attempted to restart the injector 3 times.Because a patient was waiting, a different scanner was used for the study.Once returning to the problem injector, i attempted a few more restarts and tried to remove the syringes in the injector.A puddle of water was noted to be on the floor at this time.When i inverted the head of the injector (as i would for any exam) water began pouring out of the head of the injector.Upon realizing this, the injector was shut off for safety.There is a spike that is used to load saline into one of the syringes, when the spike is twisted onto the syringe it cracks the spike.Then it lets the saline run down into the injector.Which causes the injector to malfunction.There is a spike that is used to load saline into one of the syringes, when the spike is twisted onto the syringe it cracks the spike.Then it lets the saline run down into the injector.Which causes the injector to malfunction.Findings upon further investigation: there is a spike that is used to load saline into one of the syringes, when the spike is twisted onto the syringe it cracks the spike.Then it lets the saline run down into the injector.Which causes the injector to malfunction.The problems seem to be happening with the syringe kits with a manufacturing date of 11/21/2017.Multiple kit failures noted.Defective kits returned to manufacturer for investigation.

• Brand Name: FASTLOAD CTA DUAL SYRINGE PACK WITH SPIKES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS/ BRACCO INJENEERING S.A.
• MDR Report Key: 7464717
• Report Number: MW5076790
• Device Sequence Number: 11071111
• Product Code: DXT
• UDI-Device Identifier: 17630039300873
• UDI-Public: (01)17630039300873
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: 017355
• Device Catalogue Number: 017355
• Device Lot Number: IAMV0-1711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention