MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Lot Number L01940-0006

Device Problems Protective Measures Problem (3015); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/19/2019

Event Type  malfunction  

Event Description

Pt is on centrimag as vv ecmo.The motor housing unit began making a noise and was hot to touch.The speeds on the ecmo decreased from 4500 to 3200 and there was an m4 alarm stating that it was unable to maintain speeds.At that same time the flow stopped reading and there was another alarm on the screen stating it was unable to read flow.The flow probe was still in place.The flows were reading dashes and not showing up on the monitor.The patient began to desat so the patient was switched to his back up console.

• Brand Name: CENTRIMAG
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8721605
• MDR Text Key: 148761055
• Report Number: 8721605
• Device Sequence Number: 1
• Product Code: KFM
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: L01940-0006
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA