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

Model Number 46-4

Device Problems Chemical Problem (2893); Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to manufacturer.

Event Description

On 5th march, 2020 getinge became aware of an issue with one of the washer-disinfectors, 46-4.As it was stated, the technician noticed issue with detergent dosing system, including squeezed detergent tube and mixed detergent hoses (resulting of pumping the lubricant instead of cleaning detergent).We were not able to establish for how long the detergents dosing was incorrect and if the loads affected was used.There was no injury reported however we decided to report the issue based on the potential as the issue may affect the final result of the cleaning process and the uncleaned good may have been used to the patients¿ treatment.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find total of 2 reportable customer product complaints for mixed detergents on 46-5 devices.When the event occurred, the device was directly involved and may not have met its specification, since due to the mixed detergent hoses, the cleaning and disinfecting process could have been affected.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2008-produced, type 46-5 washer disinfector.The received allegation was related to the detergent dispensing system¿s issues.The technical malfunction found was related to squeezed tubes, which appear to be an effect of the part wearing.Those parts should be checked on regular basis and replaced, if necessary.In addition, a technician found a mixed detergent, of which the customer seemed to be not aware.This triggered the reporting of this particular complaint.During the investigation course, we were able to establish that the mixed detergents were not getinge branded.This happened most likely due to user error, which most likely took place while changing the detergents and because of the dosing hoses being put to the wrong detergent bottles.The technician was able to solve the problem by replacing the squeezed hoses and connecting the detergent bottles in a correct way.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).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The purpose of this submission is to provide a correction of model number included in 'additional mfg narrative' (h10) section.This is caused by the typo made by getinge employee by mistake.Corrected data: previous h10: when reviewing reportable events for this type of issues we were able to find total of 2 reportable customer product complaints for mixed detergents on 46-5 devices.When the event occurred, the device was directly involved and may not have met its specification, since due to the mixed detergent hoses, the cleaning and disinfecting process could have been affected.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2008-produced, type 46-5 washer disinfector.The received allegation was related to the detergent dispensing system¿s issues.The technical malfunction found was related to squeezed tubes, which appear to be an effect of the part wearing.Those parts should be checked on regular basis and replaced, if necessary.In addition, a technician found a mixed detergent, of which the customer seemed to be not aware.This triggered the reporting of this particular complaint.During the investigation course, we were able to establish that the mixed detergents were not getinge branded.This happened most likely due to user error, which most likely took place while changing the detergents and because of the dosing hoses being put to the wrong detergent bottles.The technician was able to solve the problem by replacing the squeezed hoses and connecting the detergent bottles in a correct way.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.Corrected h10: when reviewing reportable events for this type of issues we were able to find total of 2 reportable customer product complaints for mixed detergents on 46-series devices.When the event occurred, the device was directly involved and may not have met its specification, since due to the mixed detergent hoses, the cleaning and disinfecting process could have been affected.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2008-produced, type 46-4 washer disinfector.The received allegation was related to the detergent dispensing system¿s issues.The technical malfunction found was related to squeezed tubes, which appear to be an effect of the part wearing.Those parts should be checked on regular basis and replaced, if necessary.In addition, a technician found a mixed detergent, of which the customer seemed to be not aware.This triggered the reporting of this particular complaint.During the investigation course, we were able to establish that the mixed detergents were not getinge branded.This happened most likely due to user error, which most likely took place while changing the detergents and because of the dosing hoses being put to the wrong detergent bottles.The technician was able to solve the problem by replacing the squeezed hoses and connecting the detergent bottles in a correct way.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.

• Brand Name: 46-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9835352
• MDR Text Key: 200052078
• Report Number: 9616031-2020-00013
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

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: 46-4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/09/2020; 04/22/2020
• Supplement Dates FDA Received: 04/21/2020; 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1