MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number CM320-2

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 8th november, 2019 getinge became aware of an event related to the cm320-2 washer disinfector.As it was stated, the customer opened the service door and was sprayed in the face directly from the output hose.The detergent used at that time was a getinge detergent heavy soil ¿ an alkaline detergent, which in case of direct contact can cause severe skin irritation.Fortunately, there was no adverse consequences of this issue.We decided to report this case based on the potential for serious injury, if the situation was to reoccur.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Initially, getinge became aware of an event suggesting that the customer opened the service door and was sprayed in the face directly from the output hose.As it was later on clarified, the detergent sprayed towards the customer, fortunately it did not reach the operator¿s body.When reviewing reportable events for this type of issues we were able to establish that this is the 1st customer product complaint registered in the getinge complaint handling systems for issues where detergent, named heavy soil, sprayed from hoses towards the customers.When the event occurred, the device did not meet its specification and it contributed to event.Upon the event occurrence the device was not being used for patient treatment.During the investigation course, we were able to establish the reason for issue occurrence was related to a damaged hoses within the detergent dispensing system.The damaged most likely occurred due to the corrosion and mechanical wear of the hose.As those hoses are made of the rubber, which deterioration is depended on the chemical ingredients used, the manufacturer is recommending user via user manual to check the part¿s condition daily and replace, if found damaged.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: CM320-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9327629
• MDR Text Key: 200048725
• Report Number: 9616031-2019-00036
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CM320-2
• Device Catalogue Number: CM320WD-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other