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

Model Number 3007301

Device Problems Melted (1385); Failure to Power Up (1476); Smoking (1585); Device Displays Incorrect Message (2591)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The site reported the following: a ct technologist reported that an error message was displayed on the injector, "3026 error up boot up" and the unit failed to power up.Emergency service was dispatched.A bayer service representative reported that the heat maintainer was melted at the tip and the injector unit was full of smoke upon opening.There was no injury or adverse event reported as a result.

Manufacturer Narrative

Bayer service performed a service checkout of the stellant injector (sn # (b)(4)) on (b)(6)2014 and determined that the system error occurred due to inoperable power supplies.The problem was traced to a shorted heat maintainer.The faulty components were replaced in the field and the system was returned to normal operating condition.Bayer r and i quality assurance product analysis received and examined the subject heat maintainer and associated parts.Visual examination confirmed extensive heat damage to the returned components.A short circuit was identified on the internal wiring assembly that led to the observed damage.The short circuit was initiated due to heating from an overcurrent condition within the heat maintainer power system.The reported problem was caused by a product malfunction since the heating and resulting short circuit condition is outside the product's design intent.

• Brand Name: STELLANT DUAL CT INJECTOR
• Type of Device: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; indianola PA
• Manufacturer Contact: linda mcdonald ; 1 bayer dr.; indianola, PA 15051 ; 7249407412
• MDR Report Key: 3739210
• MDR Text Key: 4308071
• Report Number: 2520313-2014-00015
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• 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: 02/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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