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

Catalog Number 102953

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

Patient Problems Stroke/CVA (1770); Death (1802); Thrombus (2101)

Event Date 12/31/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 27 days.The event occurred at (b)(6).It was reported that the device was disposed of at the hospital and would not be returned for evaluation.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was placed on extracorporeal circulatory support on (b)(6) 2017.It was reported that on (b)(6) 2017, a ct scan was performed due to stroke.On (b)(6) 2018, thrombus was found in the circuit, and the pump was exchanged.After the pump exchange, the patient experienced another stroke, lost consciousness, and deteriorated.The patient subsequently expired on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

The centrimag blood pump was not returned to abbott for analysis.The report of thrombus within the centrimag pump circuit could not be confirmed.Additionally, a correlation between the centrimag blood pump and the report of stroke could not conclusively be determined through this evaluation.The centrimag blood pump instructions for use (ifu) states that the pump has not been qualified through in vitro, in vivo, or clinical studies for long-term use (longer than 30 days).This document also lists embolic phenomena as possible side effects 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, this ifu 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, including the sterilization and packaging documentation, found no deviations from manufacturing 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; ch-8005 zurich 94588 ; SZ 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7510103
• MDR Text Key: 108092311
• Report Number: 2916596-2018-01736
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

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 Catalogue Number: 102953
• Device Lot Number: L04623-LA02
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/21/2018
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 37