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

Model Number 102953

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

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 06/11/2019

Event Type  Death  

Manufacturer Narrative

Approximate age of device: presently unavailable.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 bilateral centrimag support on (b)(6) 2019.It was reported that the patient expired on (b)(6) 2019 due to cardiogenic shock.The left ventricular support centrimag was explanted on (b)(6) 2019 and withdrawal of care occurred while the patient was on the right ventricular support centrimag.No equipment will be returned for evaluation.No further information was provided.

Event Description

The right ventricular support centrimag was explanted on (b)(6) 2019 and withdrawal of care occurred while the patient was on the left ventricular support centrimag.No equipment will be returned for evaluation.No further information was provided.

Manufacturer Narrative

The right ventricular support centrimag was explanted on (b)(6) 2019; care was withdrawn while the patient was on the left ventricular support centrimag.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported event could not conclusively be established through this evaluation.It was reported that pump would not be returned for evaluation.The centrimag blood pump ifu lists death as an adverse event that may be associated with the use on the centrimag vad.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8787011
• MDR Text Key: 150950855
• Report Number: 2916596-2019-03289
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG BLOOD PUMP MODEL NUMBER 102953.; CENTRIMAG BLOOD PUMP, SERIAL NUMBER (B)(4).
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 121