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U.S. Department of Health and Human Services

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

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STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  No Answer Provided  
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified damage on the chamber and press gasket.The damage created a small hole which subsequently allowed for water to leak from the unit.Section 1 of the operator manual for the reliance synergy washer/disinfector states, "to prevent slips, keep floors dry.Promptly clean up any spills or drippage.For spills or drippage of detergents or other chemicals, follow safety precautions and handling procedures set forth on detergent or chemical label and/or material safety data sheet (msds)." the investigation of this event is currently in process.A follow up mdr will be submitted once additional information becomes available.
 
Event Description
The user facility reported their reliance synergy washer/disinfector was leaking water.No report of injury or procedural delay or cancellation.
 
Manufacturer Narrative
A steris field service technician inspected the unit and identified that water was leaking due to a damaged press gasket.During inspection of the washer, the technician tested the unit and confirmed that all cycles were completed successfully.As the unit is operational, the user facility has elected to defer further repair to the unit until the washer can be decommissioned for repairs.
 
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Brand Name
RELIANCE SYNERGY WASHER/DISINFECTOR
Type of Device
WASHER/DISINFECTOR
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 Key5261008
MDR Text Key32754091
Report Number9680353-2015-00082
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/02/2015
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? No
Initial Date Manufacturer Received 11/03/2015
Initial Date FDA Received12/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/17/2016
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 Number1
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