MAUDE Adverse Event Report: GETINGE DISINFECTION AB 90-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 9027

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware with issue where the pump was leaking.According to the information provided by the customer unit did not display any alarm codes.During inspection at the customer site, the getinge representative confirmed correct error appearance and that the user was acknowledging the alarm and repeatedly running the unit, without having the source of the leak fixed.Fortunately no adverse consequences was reported.Nevertheless, we decided to report this issue based on potential risk related to loads being process with the error condition being ignored by the user, what could result in incorrectly processed loads being used.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The purpose of this submission is to provide a correction of manufacture date#.This is based on the result of an internal review noting the initial report was incorrectly submitted stating another manufacture date.#h4: previous manufacture date#: 2015-04-23, corrected manufacture date#: 2015-04-21.

Event Description

Manufacturer reference number (b)(6).

Manufacturer Narrative

On 1st july, 2020 getinge received a customer allegation regarding the leaking of a pump that is attached to the washer disinfector.The leaking is alleged to have caused water entering the mechanical / device room due to this issue.The unit was reported as not showing error codes.During the inspection at the customer site however, the getinge representative did confirm that the error had been displayed on the device and that the operator ran the machine despite the alarm condition.The customer was informed to not use the device until the source of the leak, in this case established as a lack of circulation pump plug, is fixed by the qualified personnel.Upon next arrival at the customer site, the getinge technician confirmed that the unit was not excluded from use and, since the last service visit, the customer attempted to complete disinfection cycles in it and the customer attempted to repair it by themselves, a repair which the customer not trained for.The affected device is washer disinfector 9027 manufactured on 21st april, 2015.We were able to establish that this issue is the 2nd reportable customer product complaint, within last 5 years, related to the situation where the user acknowledged the alarm displayed on the device and yet repeated ran the use cycle.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death, to the best of our knowledge.When the event occurred, the washer-disinfector did not meet its specification as a leakage occurred.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment but it certainly played a role in the reported event.During the investigation course we were able to establish, that the alarm codes displayed on the device as per the design and adequate to the situation ¿ showing a leakage from the circulation pump.As it was established, the circulation pump was leaking due to a missing plug, which most likely has been disassembled by an unauthorized person.The root cause of this reported event was identified as a user error; since the user did not follow the recommendation and continued to use the device, even although an error was discovered during the cycle.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: 90-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10332014
• MDR Text Key: 202213935
• Report Number: 9616031-2020-00026
• 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: 11/03/2020

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: Health Professional
• Device Model Number: 9027
• Device Catalogue Number: 9027-002
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 10/07/2020
• Supplement Dates FDA Received: 09/11/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1