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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 88-5
Device Problems Insufficient Flow or Under Infusion (2182); Chemical Problem (2893); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturer.Device not returned to the manufacturer.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with one of the washer-disinfectors, 88-5.As it was stated, the customer noticed error related to the detergent flow on the machine.The error occurred due to the detergent pump motor malfunction.During the troubleshooting the technician found mixed detergent hoses (resulting of pumping the lubricant instead of enzyme).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.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
When reviewing reportable events for this type of issues we were able to find total of 4 reportable complaints for mixed detergents on 88-5 devices, reported to company¿s complaint handling system within last 5 years.When the event occurred, the device did not meet its specification as due to the mixed detergent hoses the cleaning and disinfecting process could have been affected.Moreover the detergent pump malfunction occurred, most likely related to the prolonged use of the device and normal ware of this part.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2011, type 88-5 washer disinfector.During the investigation course, we were able to establish that the enzyme and lubricant detergents were mixed in the device.This happened most likely due to user error, which 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.Due to this fact, the technician was able to first replace the detergent pump motor and then place the 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.
 
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Brand Name
88-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
MDR Report Key10129183
MDR Text Key196912063
Report Number9616031-2020-00021
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 company representative,user f
Type of Report Initial,Followup
Report Date 07/01/2020
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 Number88-5
Device Catalogue Number88-303-CTOM
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/17/2020
Initial Date FDA Received06/08/2020
Supplement Dates Manufacturer Received06/19/2020
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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