MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. CENTURY LOADING CART; LOARDING CART TO STERILIZER

Device Problem Failure to Align (2522)

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

Event Date 01/05/2017

Event Type  No Answer Provided  

Manufacturer Narrative

No report of injury, procedure delays or cancellations.The user facility reported that as the loading car did not latch properly to the transfer carriage it caused the loading car to almost fall off the transfer carriage.The operator manual states (pp.5-5), "verify that loading car is securely fastened to the transfer carriage".A steris technician arrived on-site to inspect the unit and observed that the loading car easily released from the carriage during the time of the reported event.Upon inspection, the technician adjusted the latching components including checking the tightness of the hardware and replacing the springs, tested and confirmed the unit to be operational, and returned the unit to service.

Event Description

The user facility reported their loading car was not latching properly to the transfer carriage creating a potential for the loading car to detach from the transfer carriage.

• Brand Name: CENTURY LOADING CART
• Type of Device: LOARDING CART TO STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6297371
• MDR Text Key: 66665501
• Report Number: 3005899764-2017-00005
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: 01/05/2017
• 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