MAUDE Adverse Event Report: GETINGE/MAQUET CARDIOPULMONARY GMBH MAQUET ROTAFLOW; PUMP, CARDIOPULMONARY BYPASS

Model Number SN90437235

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/20/2019

Event Type  Injury  

Event Description

Console alarmed and said error.Console stopped flowing on patient and pt's stats dropped and pt became hypotensive perfusionist at bedside.Perfusion states console changed within 5 seconds.Patient vital signs stable and achieved adequate oxygenation/flows after console change.Fda safety report id # (b)(4).

• Brand Name: MAQUET ROTAFLOW
• Type of Device: PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): GETINGE/MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 8749172
• MDR Text Key: 149792543
• Report Number: MW5087707
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2019

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 Model Number: SN90437235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 23