MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8666

Device Problems Failure to Disinfect (1175); Failure to Pump (1502)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

Event Description

On 10th march 2020 getinge became aware of an issue with one of the washer disinfectors - 8666.As it was stated, the ezymatic detergent was not pumped to the washer and the customer was not aware of this issue.There was no injury reported, however we decided to report the issue in abundance of caution that any non-properly cleaned goods may be used to patient treatment and be a source of cross-infection.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On 10th march 2020 getinge became aware of an issue with one of the washer disinfectors - 8666.As it was stated, the enzymatic detergent was not pumped to the chamber properly.There was no injury reported, however we decided to report the issue in abundance of caution that any non-properly cleaned goods may have been used for the patient treatment and hay have become a source of cross-infection.When reviewing previous events, we were able to establish that the complaint in one of several pointing to the situation where the washing detergent was not pumped to the chamber properly and this fact could lead to undetected failed cleaning.As it was indicated in the complaint record, the device involved 8668 washer disinfector with serial number (b)(6).The unit was manufactured on 21st november, 2019 and installed on 23rd december, 2020.During the investigation course it was established that the pump hose was incorrectly installed in the detergent pump.The hose should be installed in the detergent pump in a proper way according to the instruction given in the installation manual for 86-series devices (6002009502 rev.G).To finalize the successful installation, the final check of the unit needs to be done, including the detergent pumping check.If the instructions would have been followed, the issue would most likely be avoided and the wrong mounted hose would have been noticed and corrected.To sum up, the most likely root cause of an issue was related to not following the instruction during the installation process.It was established that when the event occurred, the affected device did not meet its specification.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.The problem has been resolved by the pump hose installation correction.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: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 11554270
• MDR Text Key: 243128930
• Report Number: 9616031-2021-00007
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1