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

Model Number 3007301

Device Problem Fire (1245)

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

Event Date 06/10/2016

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 product analysis quality assurance reviewed photos of the affected heat maintainer.In addition the affected product is being returned for evaluation, but has not yet arrived.A follow up report will be submitted once the investigation is completed.

Event Description

The following information was received from a bayer representative: a customer reported that a heat maintainer caught fire on a stellant d injector system.There was no patient involvement.The customer responded by turning off the power to the system and used a co2 extinguisher to ensure no further flame.There was no staff or patient injury.

Manufacturer Narrative

Bayer service performed a site visit and replaced the injector head and heat maintainers.This returned the system to normal operation.Bayer product analysis quality assurance received and examined the returned heat maintainer cable assembly and confirmed thermal degradation of the connector.It was determined that contrast media build-up led to the degradation of the heat maintainer connectors.The cause of the reported problem is conductive contrast entering the connection system and creating a current path between the conductors.This event was initiated by an accidental contrast spillage and is not a product malfunction.Due to potential for burn/injury due to a high surface temperature hazard this event is reported; however, there was no injury or property damage during this event.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 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; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 5774736
• MDR Text Key: 49763716
• Report Number: 2520313-2016-00035
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3007301
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2011
• 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