MAUDE Adverse Event Report: GETINGE USA / MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA# SET ADVANCED 7.0; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Lot Number 70134574-0157034575

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Part caused ecmo machine and or circuit to machine to not work properly.The "flow" was not working correctly.Fda safety report id# (b)(4).

• Brand Name: BEQ-HLS 7050 USA# SET ADVANCED 7.0
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): GETINGE USA / MAQUET CARDIOPULMONARY GMBH; rochester NY 14623
• MDR Report Key: 10472213
• MDR Text Key: 205191145
• Report Number: MW5096338
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2020

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 Lot Number: 70134574-0157034575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR