MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-90411

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2018

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the healthcare professional stated while performing ecmo/cmag checks in the intensive care unit (icu) the cmag console started alarming.The console noted motor failure on the monitor of the cmag and noted the flow.The healthcare professional checked patient, circuit, blood flow and cmag blood pump rotor rotating appropriately.The patient vital signs were normal and no signs of distress.The connections behind console was checked and the flow probe moving it to another location on the tubing and still no flow noted on console or motor.The decision was made to change out patient circuit and the cmag console and motor.Reportedly, no adverse event occurred to patient.The alarm resolved and no further issues.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: no products were returned for evaluation.Both the cmag console and cmag motor were retained by the hospital.The reported event of no flow displayed could not be confirmed and a root cause could not conclusively be determined through this evaluation.The centrimag primary console operating manual states the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.It is also recommended to exchange of the flow probe.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console to continue patient support.Table 12 outlines the operator responses to all primary console alarms and alerts.Review of the device history record for centrimag primary console s/n (b)(4) showed the unit was manufactured in accordance with manufacturing and quality assurance specifications.No further information was provided.The manufacturer is closing the file one this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 7641727
• MDR Text Key: 112463041
• Report Number: 2916596-2018-02550
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6307880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1