MAUDE Adverse Event Report: GETINGE DISINFECTION AB 8666; DISINFECTOR, MEDICAL DEVICES

Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are aware that this is past the 30 day deadline for reporting.We have reminded the complaint handler to review fda reporting guidelines in order to prevent this from happening again.The issue is being investigated by manufacturing site.This report is being filed under exemption e2017050 by the manufacturer getinge disinfection ab (registration no.9616031) on behalf of the importer getinge group logistic america, llc (registration no.3012092534).H3 other text : device not returned to the manufacturer.
Event or Problem Description
On (b)(4) 2019 getinge became aware of an issue with one of the washer-disinfector: 8666.As it was stated, a wrong detergent was used during washing disinfection procedure.There was no injury reported, however with the information available we were not able to confirm how long a wrong detergent was used.We decided to report this issue based on the potential and in abundance of caution as incorrect detergent was used and could affect the final effect of the process.(b)(4).
Additional Manufacturer Narrative
Upon performing our investigation, we were able to establish that this issue is the 2nd reportable customer product complaint related to the issue where the incorrect detergent was dispensed on the device due to user mistake leading to the potential that incorrectly cleaned loads were used on patient treatment.The device involved in the issue is washer disinfector 8666 washer disinfector with the serial number (b)(4).The unit was manufactured on 13th april, 2015 and installed on 20th july, 2016.As it was stated in the initial report, a wrong detergent was used during the washing disinfection procedure.The issue was noticed by the customer¿s biomed technician and reported to the getinge representative.It was stated that ¿power con neutral ph¿ detergent was replaced on dosing pump 2 by the user of the device with ¿tech quat¿ sanitizer and the load was processed.After the issue was noticed, the goods from the load were reprocessed in another device.As a remediate action the device was flushed with water and correct detergent was installed on the machine and it was returned for the customer usage.During the investigation it was established that user manual contain appropriate instructions regarding the detergent choice, installation of the detergent containers and recommended detergent list.In addition, the user manual contains instructions for detergent container replacement including labeling the lead between the detergent wand and the detergent pump with the product name from the detergent container if customer is being use detergent from the getinge range or other company.Moreover, if tag and marking tape are missing from the lead between the detergent wand and the detergent pump, the customer is to contact the getinge representative to verify the correct chemical agent (detergent) is being installed and used.For the situation at hand, we were not able to establish who authorized the use of incorrect detergent during the process and for how long it has been used.Last preventive maintenance on this device was performed by getinge representative on 11th march, 2019 and no anomalies regarding the detergent choice were noticed.Based on the information collected to date it can be concluded that the possible root cause of the issue was user choosing to use an incorrect detergent.In summary, when the event occurred, the device did not meet its specification and it contributed to the situation.There is no confirmation if the device was being used for medical devices involved in patient treatment at the time when the situation occurred.Given the findings of this investigation which confirms the correct functioning of the device, and the situation having been created solely by use error, getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.
Event or Problem Description
Manufacturer reference number: tw(b)(4).

• Brand Name: 8666
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 8619061
• Report Number: 9616031-2019-00012
• Device Sequence Number: 1560396
• Product Code: MEC
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1