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

Model Number 81058881

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

A bayer service representative visited the site and replaced the injector head and power supply.Based on the limited information, we are unable to determine the root cause of the alleged incident; however, the equipment is scheduled to return to (b)(4) for a full evaluation.Once the evaluation is completed, a follow-up report will be submitted.

Event Description

The customer had reported seeing smoke coming out of the stellant ct injector head.The injector was powered down and unplugged from the wall.No injury or adverse event was reported.

Manufacturer Narrative

Bayer radiology product analysis received and examined the subject injector head.Visual examination found evidence of contrast media residue within the circuit path which led to the degradation of the heat maintainer connector.Product analysis determined the cause of the reported problem to be an accidental spill of conductive contrast media entering the connection system and creating a current path between the conductors.A high current condition resulted causing minimal localized material deformation and degradation of the surrounding plastic connector and wiring insulation.

• Brand Name: STELLANT DUAL CT INJECTOR
• Type of Device: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 6803216
• MDR Text Key: 83226022
• Report Number: 2520313-2017-00053
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 81058881
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2012
• 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