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

Model Number 58746456

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Bayer service performed a site visit and replaced the injector head and heat maintainers.This returned the system to normal operation.Bayer quality assurance product analysis received and examined the subject injector head.Visual examination of the returned component found extensive thermal degradation of the heat maintainer connection system component.Close examination of the head connector found evidence of contrast media residue within the circuit path.The cause of the reported problem was an accidental spill of conductive contrast media entering the connection system and creating a current path between the conductors.The stellant operations manual warns to "avoid fluid entry into system components." "note: if contrast medium has leaked inside any component of the system, the affected subassembly should be disassembled and cleaned by services personnel or returned to bayer healthcare services.".

Event Description

The customer had reported that the syringe heat maintainer on their stellant d injector was observed to smoke and appear burnt.The fire alarm was activated, resulting in a response from the local fire department.The customer responded by turning off the power to the room.There was no adverse event or injury reported.

• Brand Name: CT INJECTION SYSTEM
• Type of Device: STELLANT DUAL CT INJECTOR
• 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: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 6417367
• MDR Text Key: 70558053
• Report Number: 2520313-2017-00017
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58746456
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2011
• 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