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

Model Number 102953

Device Problem Infusion or Flow Problem (2964)

Patient Problems Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

The serial number of the device is not known.The device packaging and serial number information was disposed of.The approximate age of device: is not known.The device manufacturer date is not known.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.The patient was removed from support, and the perfusionist reported a large blood clot in the blood pump around the rotor.There were no alarms and no patient issues associated with the thrombus.The thrombus was not discovered under support was discontinued.No additional information was provided.

Manufacturer Narrative

The pump was disposed of at the user facility and was therefore not available for evaluation.The report of a blood clot in the blood pump could not be confirmed nor correlated to a device related issue.It was reported that there were no alarms or patient issues.Thromboembolic phenomena are listed in the instructions for use as potential adverse events that may be associated with the use of the centrimag blood pump and warns the user to monitor the circuit carefully for any signs of occlusion.Additionally, the instructions for use explains that the pump is intended to be used with systemic anticoagulation and instructs the user to always have a spare centrimag blood pump, back-up console, and equipment available for change out.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.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; zurich 8005 ; SZ 8005
• 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: 6553039
• MDR Text Key: 74702091
• Report Number: 2916596-2017-00925
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• 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: 06/14/2017

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
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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