MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR INSTRUMENT RACK

Device Problem Residue After Decontamination (2325)

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

Event Date 05/12/2015

Event Type  No Answer Provided  

Event Description

The user facility reported the presence of black residue on their reliance synergy washer/disinfector instrument rack.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

The investigation of this event is currently in process.A follow-up mdr will be submitted once additional information becomes available.

Manufacturer Narrative

A steris field service technician arrived onsite and inspected the reliance synergy washer/disinfector instrument rack.The technician identified black residue on the inside of the tubing.During the inspection the technician confirmed the reliance synergy washer/disinfector was operating according to specification.Water sample testing was conducted and it was identified that the user facility's water contained contributed to the reported residue on the inside of the tubing.Steris will communicate the results of the water testing to the user facility.The reliance synergy washer/disinfector maintenance manual states in section 2: service mode procedure, "maximizing the efficiency and the life of the washer/disinfector is predicated on the type of water and the cleaning chemistries used.The corrosive effects of water (deionized, soft and hard water) and contaminants found in water (such as hardness cations, corrosive anions, metals, etc.) can shorten the useful life of both instrumentation and equipment.Hard water can result in scale formation as well, which can deposit on both equipment and instrumentation." section 5: routine maintenance and replacement parts of the operator manual for the rigid mis instrument rack states, "accessory must be inspected regularly to help ensure no sediment has accumulated in spray header, rubber caps and silicone tubing," and "inspect rubber caps and silicone tubing.Replace if torn, discolored or damaged." the unit is not under steris contract agreement for maintenance and the user facility is responsible for maintenance of this accessory.Steris has conducted in-service training with the user facility on the proper use and operation of the washer and its accessories.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR INSTRUMENT RACK
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4840622
• MDR Text Key: 5940709
• Report Number: 9680353-2015-00038
• Device Sequence Number: 1
• Product Code: MEC
• 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,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• 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: 05/13/2015
• 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