MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	46-4
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information received from the hospital indicated that insufficiently cleaned items were identified on one of the washers.An investigation at the facility revealed that the tube connecting the cleaning tank and washer had become loose, and that the cleaning process indicator showed poor cleaning results, which were unfortunately overlooked.In response to this incident, the facility collected all items cleaned during the relevant period, replaced detergent tubes across all washer units, including the affected washer, installed detergent flow meters, and reviewed in-house procedures.Additionally, they have implemented or planned re-education programs.While no health impacts have been reported in relation to this issue, we are submitting this report in an abundance of caution, as inadequately cleaned items used in patient treatment could pose a risk of infection.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
Information received from the hospital indicated that insufficiently cleaned items were identified on one of the washers.An investigation at the facility revealed that the tube connecting the cleaning tank and washer had become loose, and that the cleaning process indicator showed poor cleaning results, which were unfortunately overlooked.While no health impacts have been reported in relation to this issue, we are submitting this report in an abundance of caution, as inadequately cleaned items used in patient treatment could pose a risk of infection.The product involved in the customer product complaint is the 46-series device, model name: 46-4 with the serial number: (b)(6).The unit was manufactured on 14th september 2017 and installed on 10th march 2018.Despite signs that the goods were not processed correctly, the customer approved the faulty load.The issue stemmed from a detergent hose malfunction, preventing detergent transfer to the machine chamber.The customer have to follow the user manual's safety guidelines.Additionally, regular service, which includes checking and replacing hoses as per the service manual, was not performed as required, leading to the issue.Failure of the operator to follow the manual is directly related to user error.Failure to properly follow preventive maintenance routine is related to maintenance error.When the event occurred, the device was directly involved and not meet its specification.Upon the event occurrence the device was not being used for patient treatment.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: 46-SERIES
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: maria elovsson ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 20579666
• Report Number: 9616031-2024-0000036
• Device Sequence Number: 18273026
• Product Code: MEC
• UDI-Device Identifier: 07340153700031
• UDI-Public: (01)07340153700031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Model Number: 46-4
• Device Catalogue Number: 46-4-402-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown