MAUDE Adverse Event Report: BELIMED AG BELIMED WASHER/DISINFECTOR WD290

Model Number	WD290
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The disinfection parameters of a washer/disinfector program were changed at a healthcare facility by a third party technician employed by the facility's chosen detergent manufacturer.The facility's intention was to shorten the total duration of the reprocessing cycle by elevating the temperature for disinfection and cutting back the time.However, the disinfection step was erroneously set to "flush" instead of "disinfect." the change resulted in omission of the disinfection cycle.The incorrect parameters were then copied to ten additional washer/disinfectors at the same healthcare facility.The affected "general instruments" reprocessing cycle is intended for cleaning, thermal disinfection and drying of thermostable surgical instruments.Disinfection performance was affected by the event, resulting in non-compliance with belimed's disinfection specification --an a0 value of 3000-- when the program was subsequently run by the user.Patients were not at risk at any time throughout the period during which the deficiently parameterized cycle was run at the facility.The patient-relevant reprocessing steps of the affected program are cleaning and drying, which functioned correctly at all times.In addition, the overall reprocessing procedure for thermostable surgical instruments always includes steam sterilization as the final microbicidal step.The disinfection step of the program is intended to protect the user.Lack of disinfection may put user health at risk by contact with clean but non-disinfected instruments during the process of emptying the washer and preparing the instruments for sterilization, particularly if the user is not wearing personal protective equipment.Since the faulty disinfection step was copied to 10 additional devices, this is report #2 of eleven.
Additional Manufacturer Narrative
Washer/disinfectors are delivered to a healthcare facility with a certain number of preprogrammed common reprocessing cycles that may be modified by a belimed technician during installation of the device at the facility or thereafter in accordance with user needs.However, user modification of reprocessing cycles as needed for specific items requiring cleaning and disinfection is also possible.The device manual includes detailed instructions for such adjustments.These instructions were not followed when the disinfection cycle was modified by the third party technician.The event occurred near the end of 2019 or in early 2020.All washer/disinfectors have been running at full capacity since then.The deficiently parameterized "general instruments" cycle was the most frequently run program, but not the only one.All the other programs were executed correctly.The error was detected recently by a belimed technician who had been called in by the facility to fix an unrelated, non-reportable problem with reprocessing parameters again modified deficiently by a third-party technician employed by the healthcare facility's chosen detergent manufacturer.Belimed proceeded to check all washer/disinfectors and discovered the error that is being reported in this medical device report.Belimed has corrected the parameters of the affected program to carry out the disinfection step in conformance with device specifications and user needs.The program is now running correctly.

• Brand Name: BELIMED WASHER/DISINFECTOR WD290
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 14669203
• Report Number: 3001061128-2022-00002
• Device Sequence Number: 20123224
• Product Code: MEC
• UDI-Device Identifier: 07640141626054
• UDI-Public: (01)07640141626054(11)160909
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2022

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
• Operator of Device: Other
• Device Model Number: WD290
• Device Lot Number: 25010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown