MAUDE Adverse Event Report: STERIS CANADA CORPORATION 130L CART WASHER

Device Problems Detachment Of Device Component (1104); Chemical Spillage (2894); Improper Chemical Reaction (2952)

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

Event Date 10/09/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their washer's descaler line detached during a decontamination cycle.Descaler flowed out of the washer and onto the floor.The facility's biomedical technician used a typical absorbent material which caused a chemical reaction forcing the department to evacuate the area.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

A steris field service technician arrived onsite to find the area had already been cleaned and wiped down.The technician inspected the washer and identified a hose clamp had worn and broke off allowing the descaler line to dislocate and leak.The descaler is an acid solution with a ph balance of 1.2.A typical absorbent would most likely not be able to contain an acidic solution with a ph balance of 1.2.Rather an absorbent which is made to deal with acidic solutions should have been used and would have negated any chemical reaction.Spills should be contained and can be neutralized carefully with a weak acid solution or absorbed with a suitable substance and placed in a disposal container.The user facility should rinse the contaminated zone with plenty of water and eliminate the rinse water to a sanitary sewer.The prolystica restore descaler and neutralizing detergents msds states, "do not breathe fumes, vapors.Avoid contact with skin, eyes, and clothes" and "stop leak if safe to do so.Evacuate unnecessary personnel." the msds provides guidelines for handling the descaler: wear rubber gloves, chemical splash goggles, suitable protective clothing (long sleeves and boots), and appropriate masks for personal protective equipment.

• Brand Name: 130L CART WASHER
• Type of Device: CART WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4232426
• MDR Text Key: 4976486
• Report Number: 9680353-2014-00092
• 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: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/06/2014
• 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