MAUDE Adverse Event Report: MAQUET SAS MODUTEC; TUBING, PRESSURE AND ACCESSORIES

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 1st july, 2020 getinge became aware of an issue with one of devices- modutec.As it was stated, the seal was found cracked.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of devices- modutec.As it was stated, the seal was found cracked.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the device did not meet its specification as the seal should not crack and it contributed to incident.There is no information if when the event occurred the device was or was not being used for patient treatment.The tearing and cracks observed on the rubber¿s bellows are probably due to the age.According to their aspect they are probably very old (more than 10 years).They should have been changed earlier because this type of damages appears over time and can easily be detected during preventive maintenance.A preventive maintenance carried out every year would avoid the complete tearing.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MODUTEC
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10243890
• MDR Text Key: 198174838
• Report Number: 9710055-2020-00206
• Device Sequence Number: 1
• Product Code: BYX
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1