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

Model Number 201-90010

Device Problems Air Leak (1008); Noise, Audible (3273)

Patient Problem Air Embolism (1697)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient's age, gender and weight were not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on biventricular extracorporeal circulatory support.It was reported that 7 days after implant on (b)(6) 2018, low flow alarms occurred and air bubbles were observed during echocardiography of the right ventricle.The patient also developed dark urine.Noise from the pump was heard.A decision was made to stop the pump and exchange the motor.Patient support and pump flow resumed back to normal.The patient's urine went back to normal.No additional information was provided.

Manufacturer Narrative

The lot number of the device was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Additional information: clarification was provided indicating that the healthcare professionals believed the issue was the motor as the pump head was not exchanged.They only changed the motor with the same pump head.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the device was not returned for evaluation.A correlation between the reported event and the blood pump could not conclusively be determined through this evaluation.Additionally, a root cause for the event could not conclusively be determined.The centrimag blood pump instructions for use (ifu) states to monitor the arterial line for air because the centrimag blood pump, similar to other centrifugal pumps, will pump air.Stop infusion if air enters the pump as gaseous emboli may be introduced into the patient.It also states to determine the proper position for the pump in the extracorporeal circuit.It also states to always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3: correction.

• Brand Name: CENTRIMAG BLOOD PUMP, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 7550547
• MDR Text Key: 109451642
• Report Number: 2916596-2018-02023
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 201-90010
• Device Catalogue Number: 201-90010
• Other Device ID Number: 07640135140061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 57