MAUDE Adverse Event Report: GETINGE DISINFECTION AB WD15 CLARO; DISINFECTOR, MEDICAL DEVICES

Model Number WD15 CLARO

Device Problem Residue After Decontamination (2325)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

On 15th march, 2019 getinge disinfection ab became aware of an issue with one of the washer disinfector- wd15 claro model number.As it was stated, on 15th march during visual inspection after disinfection process, hospital staff noticed that the load was discolored and sticky.The device was inspected by getinge technician and it was noted that getinge clean alkaline detergent was wrongly dosed instead of lubricant at the final rinse phase due to the wrong selection of detergent pump.When reviewing reportable events, we were able to establish that this issue is the 1st reportable complaint related to the customer allegation where wrong detergent was used during disinfection process due to incorrect parameters set up on the ge15 device.It is considered as a single, isolated event.The product involved in the incident is a getinge washer disinfector, wd15 claro model with the serial number (b)(4).The unit was manufactured on 29th january, 2019 and installed on 9th march, 2019.The dhr was reviewed and no anomaly was found.The device was under getinge preventive maintenance (pm) agreement, however no pm was performed as the issue occurred 6 days after installation.Upon performed investigation we were able to establish that during the installation, getinge technician set up wrong dosing parameters on the device.The dosing parameters used for demonstration unit were transferred to the affected unit and this contributed to the situation where only neutral and alkaline detergents were used during disinfection process.It was also confirmed that during machine validation, the customer and technician didn't check the parameter settings on the device.The incorrect parameters remained unchanged until the incident occurred on the device.The installation manual provided with the unit contains instructions regarding checking the device after installation is completed.It includes checking of proper working of the dosing pumps and calibration of dosing pumps and dose monitoring, according to instructions provided in service manual.It was established that following the installation instructions, the issue is likely to be detected.In summary, when the event occurred, the device did meet its specification however had incorrect settings and it contributed to the event.In the time when the event occurred, the device was not being used for patient treatment.The most probable root cause of the issue occurrence is an error during the installation, therefore the technician who performed this activity was given a feedback from the investigation done and retrained in order to avoid occurrence of any similar errors in the future.Given the findings of this investigation, getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.

Event Description

On 15th march, 2019 getinge became aware of an issue with one the washer disinfector-wd15 claro.As it was stated, the alkaline detergent was dosed at the final rinse phase instead of lubricant rust inhibitor leading to washed goods became sticky.There was no injury reported however we decided to report the issue based on the potential as incorrect detergent dosing might lead to the undetected failed cleaning/disinfection of the loads and consequently to an adverse event.

Manufacturer Narrative

This report is solely to correct the a1 field 'patient identifier'.The typo mistake was caused by human error and noticed during the internal review.Old a1: (b)(6), corrected a1: (b)(6).

Event Description

Manufacturer reference number (b)(4).

• Brand Name: WD15 CLARO
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 11715364
• MDR Text Key: 250437245
• Report Number: 9616031-2021-00011
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WD15 CLARO
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2021
• Patient Sequence Number: 1