MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I, US-VERSION; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701072780 - CARDIOHELP-I, US-VERSION

Device Problem Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Cardiohelp stopped functioning during a case.What actually occurred and the date of event is unknown.Patient expired.Technician afterwards stated that the customer reported rounds per minute interruptions during flow check.Reference number: (b)(4).

• Brand Name: CARDIOHELP-I, US-VERSION
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9069596
• MDR Text Key: 158619414
• Report Number: 3008355164-2019-00015
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701072780 - CARDIOHELP-I, US-VERSION
• Device Catalogue Number: 70107.2780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/16/2019
• Distributor Facility Aware Date: 08/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death