MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; DISINFECTOR, MEDICAL DEVICES

Model Number SYNERGY

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

Or nurse submitted hero reports stating bioburden present on the loaner instruments they were getting ready to use for surgery.Found bioburden more than few trays in sterile processing department (spd).Staffs immediately pointed out their washers were not cleaning the instruments thoroughly.The devices were troubleshooted and nothing was found to be wrong with washers.Through the investigation, we found out spd technicians were not taking out the loaner instruments from the tray to scrub and pre-wash them.They would just throw in the tray in the washer without even opening them as it was brought by the representative and expected the washer to clean it out streak-free.Manufacturer response: for washers, synergy reliance (per site reporter) called steris and scheduled evaluation and maintenance service.

• Brand Name: RELIANCE
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CORPORATION; becky aldhizer; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 6955025
• MDR Text Key: 89514614
• Report Number: 6955025
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/13/2017,09/15/2017

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: No Information
• Device Model Number: SYNERGY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2017
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES