MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH / MAQUET CARDIOVASCULAR MAQUET ECMO MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Problem Loss of Power (1475)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/13/2019

Event Type  Death  

Event Description

Ecmo pump shut off while supporting pt pulmonary function.Pt went into asystole and was not resuscitated due to pt was a dnr.Fda safety report id# (b)(4).

• Brand Name: MAQUET ECMO MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH / MAQUET CARDIOVASCULAR
• MDR Report Key: 8922982
• MDR Text Key: 155332084
• Report Number: MW5089262
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• 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): Death
• Patient Age: 27 YR
• Patient Weight: 69