MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee was removing the loading car with liquid bottles from the sterilizer when one of the transfer carriage's wheels detached allowing the transfer carriage and loading car to fall to the floor.As the loading car fell the bottles spilled out onto the floor causing them to break and for hot liquid to make contact with the employee's foot.A steris service technician arrived onsite to inspect the unit and found that the bolt that secures the wheel in place had become loose subsequently allowing the wheel to detach.The technician ordered a replacement wheel assembly, replaced the wheel, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was manufactured in 2007 and is approximately 12 years old.The transfer carriage and loading car are not under a steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.Based on the technician's inspection, the root cause of the reported event can be attributed to improper maintenance of the unit.The atlas transfer carriage preventive maintenance checklist states (pg.1, section 3), "perform annually- check floor casters for wear and tighten caster assembly.Note: any worn rubber expander assemblies should be replaced with the wedge block assemblies." while onsite, the technician counseled user facility personnel on the importance of properly maintaining the unit.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a burn on their foot while removing a load from the sterilizer with an atlas transfer carriage.No medical treatment was administered.

• Brand Name: ATLAS TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9496051
• MDR Text Key: 199552490
• Report Number: 3005899764-2019-00097
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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