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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES
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GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 46-5
Device Problems Chemical Problem (2893); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2020
Event Type  malfunction  
Manufacturer Narrative
The issue is to be investigated.Device not returned to manufacturer.
 
Event Description
On 28th february, 2020 getinge became aware of an issue with one of the washer-disinfectors, 46-5.As it was stated, while checking the detergents level, which is performed regularly, it was noticed that the detergent hoses pumping alkaline and rinse detergent are switched on the device.There is no information about any alarm, which occurred on the device or if the incorrect cleaned goods were reprocessed.With the complaint at hand there was no information received that would suggest an adverse consequences for the patient involved.Nevertheless, we decided to report this complaint based on the potential for adverse outcome as the affected items could have been use 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 likely did not meet its specification as due to the mixed detergent hoses the cleaning and disinfecting process could have been affected.There was however no actual technical malfunction found within the detergent dosing system of the device.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2016, type 46-5 washer disinfector.With the received customer product complaint at hand, two allegations were received.¿ the first allegation was related with a customer annoyance and caused by the dryer fan cover making noise during device usage.The technician was able to established that this was caused by parts misalignment and solve the problem by reinstalling the cover.¿ the second issue, which also triggered the reportability for this particular complaint, was related with a detergent being mixed.During the investigation course, we were able to establish that the lubricant and alkaline detergent were mixed in the device.This happened 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.It appears that the activity was performed in a way that is not in line with information and instruction available in the product user manual.The technician was able to solve the problem by placing hoses in correct detergent bottles.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.We also recommend the customer retraining about the content of ifu.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name
46-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
MDR Report Key9785667
MDR Text Key200051343
Report Number9616031-2020-00011
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 04/09/2020
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 Number46-5
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/28/2020
Initial Date FDA Received03/04/2020
Supplement Dates Manufacturer Received04/02/2020
Supplement Dates FDA Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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