MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the washer and found a broken weld on the lower leg pinning allowing water to leak out onto the floor.The technician repaired the weld, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was installed in 2016 and is not under steris service agreement; the user facility's biomed department is responsible for all maintenance activities.No additional issues have been reported.(b)(4).

Event Description

The user facility reported via user facility medwatch report # (b)(4) that their amsco 5052 washer was leaking.The washer was inspected by user facility's biomed department who replaced the door gasket.No slip/fall hazard as the water was quickly contained.

• Brand Name: AMSCO 5052 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9413211
• MDR Text Key: 202746532
• Report Number: 9680353-2019-00048
• Device Sequence Number: 1
• Product Code: MEC
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 11/04/2019
• 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