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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6), 2019 getinge became aware of an issue with alphaport device.As it was stated, the cover of fluid delivery arm fell into operating field.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure might cause a contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

It was established that the device which was involved in this issue is not under maquet sas responsibility, but under maquet (suzhou) co.,ltd.Responsibility.Therefore, the case will be further evaluated under manufacturer report number 3007417753-2019-00002.

• Brand Name: ALPHAPORT
• 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: 9205647
• MDR Text Key: 176246682
• Report Number: 9710055-2019-00308
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1