MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP SYSTEM

Device Problem Loss of Power (1475)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/03/2021

Event Type  Injury  

Event Description

A contrast enhanced echocardiogram was performed (could not rule out lv thrombus without contrast).To avoid triggering the bubble detector, the cardiohelp was placed in global override.Cannulating physicians and backup circuit immediately available and echo completed without incident.30 minutes later (half-life of echo contrast < 2 minutes) global override turned off and cardiohelp subsequently stopped and could not be restarted.It continued to sense a flow disturbance.Patent already tenuous, so cpr initiated, and patient converted from vv to va ecmo and placed on new ecmo circuit.Manufacturer response for console, heart-lung machine, cardiopulmonary bypass, maquet cardiohelp (per site reporter): service representative from maquet tested this device with our clinical and biomedical team present on.The cardiohelp device field test was completed.The device passed all tests and is deemed completely functional.Additional data regarding alarm logs pending further analysis by maquet manufacturer or vendor.We are awaiting results.

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11816628
• MDR Text Key: 250437788
• Report Number: 11816628
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2021,05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP SYSTEM
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 19345 DA
• Patient Weight: 173