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

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/04/2018

Event Type  malfunction  

Event Description

Patient is centrally cannulated with centrimag with oxygenator.Centrimag began alarming s3 and m5.Flows dropped on screen.Mcs rn told patient rn to get cca.Mcs rn grabbed back up centrimag.Charge nurse also assisted in helping getting back up centrimag attached.Patient was probably flowless for 2-3 minutes.Cca arrived and we were able to get flows back to 6-5.9 lpm.Patient did become hypotensive during this event but once flows were achieved patient recuperated.Perfusion notified of system failure.2 more backs up brought from or.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; abbott laboratories; 100 abbott park road d-03q3, ap52-1; abbott park IL 60064
• MDR Report Key: 8163750
• MDR Text Key: 130340647
• Report Number: 8163750
• 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: 11/05/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA