MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number 58746456

Device Problems Air Leak (1008); Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problem Air Embolism (1697)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Bayer service performed a check of the injector and found it to perform to specifications.The subject disposables used during the injection were discarded at the site and the site was unable to provide the lot numbers.A bayer clinical support specialist provided retraining for the ct team.

Event Description

The customer reported the following: a ct scan of the abdomen with contrast was performed on a (b)(6) year old female being screened for pancreatic cancer, while connected to a stellant injector (serial number (b)(4)).During the contrast enhanced phase the technologist realized that a large amount of air was injected into the patient.The patient became disoriented, tachycardic and short of breath.The patient underwent a stabilizing procedure, and was admitted to the icu.The patient was discharged from the hospital 6 days later and had no sequelae or additional complications.

• Brand Name: STELLANT DUAL CT INJECTOR
• Type of Device: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: linda mcdonald ; one bayer drive; indianola, PA 15051 ; 7249407412
• MDR Report Key: 7303791
• MDR Text Key: 101236642
• Report Number: 2520313-2018-00024
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 58746456
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 93 YR