MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Catalog Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982)

Event Date 01/27/2015

Event Type  Injury  

Event Description

The patient was supported with an extracorporeal blood pumping system for right ventricle support.The patient was also implanted with an lvad on the same day ((b)(6) 2015).It was reported that on (b)(6) 2015, the patient¿s right extracorporeal circulatory support pump was explanted.The removal of the pump was a planned event and was not due to any device issues.The surgery reportedly ¿went perfect¿.The patient was not given any extra heparin iv and no bypass was used.After surgery, the patient was not waking up.On (b)(6) 2015, a head ct scan was performed which showed a hemorrhagic occipital infarction.An intracranial pressure monitor was placed, and the patient was administered anti-seizure medications.No additional information was provided.

Manufacturer Narrative

Approximate age of device ¿ 11 days.The centrimag cannulae and pump will not be returned for evaluation.No further information is available.A supplemental report will be submitted when the manufacturer's investigation is completed.Placeholder.

Manufacturer Narrative

Additional information: a full evaluation of the device and a root cause for the reported event could not be determined as no equipment was returned to the manufacturer for evaluation.No complications were noted to have occurred during explant of the right extracorporeal circulatory support pump.A review of the device history record revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the patient continues to recover.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4566826
• MDR Text Key: 5554400
• Report Number: 2916596-2015-00394
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 102953
• Device Lot Number: L03326-LA06
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS VAD-16106
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 107