MAUDE Adverse Event Report: MEDTRONIC AFFINITY CP CENTRIFUGAL PUMP MOTOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2021

Event Type  malfunction  

Event Description

(b)(4) revolutions per minute (rpm) increased per md to achieve higher cardiac output.(b)(4): cone decoupled, cone changed out in 30 seconds, cone seated however, the rpm would not increase with the knob being turned.The knob was turned back off past click and turned again up rpm would not increase past 0.This was repeated 4 times before changing the motor.The motor was taken off the backup circuit and plugged in, the rpm was increased successfully, and the patient was back on ecmo after 90 seconds.

Event Description

2116-revolutions per minute (rpm) increased per md to achieve higher cardiac output.2145: cone decoupled, cone changed out in 30 seconds, cone seated however, the rpm would not increase with the knob being turned.The knob was turned back off past click and turned again up rpm would not increase past 0.This was repeated 4 times before changing the motor.The motor was taken off the backup circuit and plugged in, the rpm was increased successfully, and the patient was back on ecmo after 90 seconds.

• Brand Name: AFFINITY CP CENTRIFUGAL PUMP MOTOR
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC; 8200 coral sea st ne # mvs74; moundsview MN 55112
• MDR Report Key: 11684917
• MDR Text Key: 245996128
• Report Number: 11684917
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Event Location: Other
• Date Report to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 77