MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Catalog Number 201-303000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2018

Event Type  malfunction  

Event Description

Patient was on venous-venous ecmo using centrimag with oxygenator.The centrimag began alarming pump failure so two rn's emergently switched the device over to the back-up controller.No harm to patient, but high potential for harm.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7533443
• MDR Text Key: 108895475
• Report Number: 7533443
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 201-303000
• Other Device ID Number: L01940-0005
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR