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

Model Number 3007301

Device Problems Fire (1245); Smoking (1585)

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

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

A bayer service representative visited the site and replaced the injector head.While on site, service noted that one of the heat maintainers had melted and broke into two pieces.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 reported seeing flame and smoke from the stellant ct injector head.The injector was unplugged from the wall and also at the back of the injector.No injury or adverse event was reported.

Manufacturer Narrative

Bayer radiology product analysis received and examined the injector head and heat maintainers.Visual examination found extensive thermal degradation of the heat maintainer connection system components as well as extensive contrast residue and resulting corrosion in several areas of the injector head back panel and connectors.Further examination of the injector head connector and the heat maintainer connector found evidence of contrast residue within the circuit path.Our investigation determined that conductive contrast had entered the connection system and created a current path between the conductors.As a result, a high current condition was created which caused material deformation and degradation of the surrounding plastic connectors and wiring insulation.The stellant operation manual contains the following warning: · 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 medrad service personnel or returned to medrad factory service.

• 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: 5243671
• MDR Text Key: 32139774
• Report Number: 2520313-2015-00055
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 3007301
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2011
• 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
• Patient Age: 57 YR
• Patient Weight: 145