MAUDE Adverse Event Report: BRACCO INJENEERING S.A. CT EXPRES; CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY

Model Number 4D

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

On 08 february 2023, the ct exprès injection system serial number (b)(4) was evaluated by a bracco injeneering service provider.The injection system was functionally tested and met pre-established specifications.The device was not returned for evaluation.Review of the device history record was completed on 03 march 2023, for the injector serial number (b)(4).This review confirmed that there were no non-conformances during manufacturing of the device related to the reported event.A complaint history review showed no previous related complaints.The ct expres consumable kits used during the event have been requested to be returned for evaluation.Upon completion of the investigation, a final report will be submitted to fda.

Event Description

The female patient had a hickman central venous catheter in which contrast medium was to be administered for a thorax abdomen computed tomography (ct) scan with a ct express 4d injection system.At the time of injection, a tubing clamp was closed on the hickman catheter, resulting in extracorporeal bursting of the hickman catheter.The patient did not sustain injury from the burst hickman catheter.The patient underwent surgery to have a new hickman catheter placed.

Manufacturer Narrative

H3: although requested, the ct express consumable kits used during the event are not available for evaluation; these items were discarded by the customer.The lot numbers of the consumables used were not provided or are not known.There was no evidence of device malfunction related to the reported event.Per the powerhickman central venous catheters instructions for use, "maximum 5 ml/sec flow rate at 300 psi pressure limit enables injection of contrast media for contrast enhanced computed tomography (cect) scans." evaluation of the available information concludes no causal relationship between the ct express injection system and the reported adverse event.

• Brand Name: CT EXPRES
• Type of Device: CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sévelin 46; lausanne, 1004 ; SZ 1004
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: teresa butler ; 7905 fuller road; eden prairie, MN 55344
• MDR Report Key: 16555012
• MDR Text Key: 311419223
• Report Number: 3004753774-2023-00002
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: K151048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4D
• Device Catalogue Number: 650208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HICKMAN CENTRAL CATHETER
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female