MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STEAM STERILIZER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported their steam sterilizer malfunctioned due to poor incoming water quality.The facility reported in (b)(4) that the event occurred on (b)(6) 2015.A review of steris service records revealed the facility contacted steris on (b)(6) 2015 to have the unit's generator replaced.Per discussion with the technician who completed the repairs, the replacement of the generator was caused by poor water quality at the facility's location.The technician reported the generators were heavily scaled causing damage to the piping gauges, pressure switches, and safety valve.The facility utilizes an ro water system; however personnel were unaware that the system required routine maintenance and service to ensure it continues to operate to specification.The facility is working on correcting the water issue at their location.

Event Description

Reference (b)(4).No injuries, procedural delays, or cancellations were reported.

• Brand Name: AMSCO 400 STEAM STERILIZER
• Type of Device: 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: 5528949
• MDR Text Key: 41543852
• Report Number: 3005899764-2016-00027
• 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: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• 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: 02/29/2016
• 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 Number: 1