MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 46-5

Device Problems Corroded (1131); Residue After Decontamination (2325); Calibration Problem (2890); Device Ingredient or Reagent Problem (2910)

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

Event Type  malfunction  

Manufacturer Narrative

Issue is to be investigated by the manufacturer.Device not returned to the manufacturer.

Event Description

On 19th june 2020 getinge became aware about the issue with the 45-6 washer/disinfector.As it was stated, the incorrect detergent dosing and incorrect process parameters, such a lack of rinse phase in the cycles was set on the device.Additionally the corrosion of the detergent hoses was found.Due to this fact the residue was found on the processed loads.Customer reported also issues with degradation of instruments after cleaning in the device.The machine was used in this state without any correction for about 6 months.We have no information about any adverse outcome due to the issue, however we decided to report the issue in abundance of caution, that any non-proper cleaned loads used for patients¿ treatment could be the source of infection.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to establish that the issue in one isolated one registered on the 46-series devices in our complaint handling system.When the event occurred, the device was directly involved and did not meet its specification.Upon the event occurrence the device was not being used for patient treatment or diagnosis.The device affected is a 2011-produced, type 46-5 washer disinfector.The received allegation was related to the issue with residue observed on the finished loads.The investigation showed that the most likely causes of the uncleaned goods which have not been correctly rinsed with water were defined as the blocked spray arms and the wrong performed descaling phase (to high dosage of descaling detergent plus lack of the rinse phase in the descaling process).The root cause was defined as a compilation of several factors: not correctly performed daily maintenance of the machine, by not checking the device spring arm if functioning correctly, setting wrong parameters excluding rising phase in the program and using to high volume of detergent.The service technician solved the problem by setting correct parameters and cleaning the spray arms.No residue was observed on the goods since the technicians¿ visit.The machine was put back in use working up to the manufacturer recommendation.We believe that had the user followed the instructions for use, the issue could have been avoided.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 46-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10288529
• MDR Text Key: 200046735
• Report Number: 9616031-2020-00024
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 46-5
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1