MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH/MEDIKOMP GMBH ROTAFLOW CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 02/28/2019

Event Type  Injury  

Event Description

The patient was on vv ecmo on maquet rotaflow for pre-lung transplantation respiratory support.The rotaflow console showed ¿error¿ message and subsequently traumatically shut off.The console was plugged into a red outlet and was functioning properly prior to this occurrence.The patient was off support for about 3-5 minutes as our team switched to a backup console.The patient went back on vv ecmo and was not harmed.

• Brand Name: ROTAFLOW CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH/MEDIKOMP GMBH
• MDR Report Key: 8386143
• MDR Text Key: 137794974
• Report Number: MW5084584
• Device Sequence Number: 0
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 72