MAUDE Adverse Event Report: MEDTRONIC, INC. BIO-CONSOLE PUMP MOTOR HEAD; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problems No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/23/2019

Event Type  malfunction  

Event Description

Patient was on ct scan table on vv emco on bioconsole 560 with pump motor head.Just before starting scan, it was noticed that the pump head malfunctioned making an atypical noise and pump flows cut out.Pump rpms were then turned down to 0 and the cone was removed from the pump motor and cone was re-seated which failed to resolve the problem.After all troubleshooting methods were exhausted, hand cranking was then initiated.Patient saturation remained normal throughout the entire event.Back up perfusion team was paged and new pump motor was plugged into existing bioconsole 560 and ecmo was resumed without issue.With the exception of the pump motor, all components of the bioconsole and disposable ecmo circuit remained viable.No further intervention was indicated and patient remains stable in icu.

• Brand Name: BIO-CONSOLE PUMP MOTOR HEAD
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea st ne # mvs74; moundsview MN 55112
• MDR Report Key: 9383143
• MDR Text Key: 168283983
• Report Number: 9383143
• 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
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA