MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Model Number 201-90411

Device Problem Device Stops Intermittently (1599)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The approximate age of device: is not known.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.Ct scan revealed a 1 cm non-occlusive wall adherent clot in intrahepatic inferior vena cava (ivc).Upon return to the unit from ct scan, the nurse observed that the centrimag pump speed was dropping from 3800 rpm to 0 rpm.It took approximately 1 minute for pump speed to return to 3800 rpm.Motor disconnect and flow below minimum alert were activated.The patient was transitioned to a different console and motor.It was reported that the patient remained supported on intravenous medication for cardiac function and blood pressure.The patient's lactate dehydrogenase (ldh) was 603u/l.No medical interventions were performed.It was reported that the place was for attempted right ventricular assist device weaning in the future.No additional information was provided.

Manufacturer Narrative

Device evaluation: the reported event of centrimag console and motor speed issues was not confirmed during the analysis.The centrimag primary console and centrimag motor were returned and evaluated.Technical services did not confirm the reported issue and the units were found to be functioning properly.A full functional test was performed and the returned console and motor passed.The units are returning to customer site.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6750347
• MDR Text Key: 81281814
• Report Number: 2916596-2017-01612
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 104