MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EMTEC PEDIATRIC FLOW PROBE, OUS; PRIMARY CONSOLE WITH PEDIATRIC FLOW PROBE

Model Number 201-90701

Device Problem Overheating of Device (1437)

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

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Describe event or problem: the reported motor was reported under mfr # 2916596-2019-01259.Approximate age of device: the console is not a single use device.Approximate age of the device will be provided with the device evaluation results.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 centrimag console and the centrimag motor presented the following anomaly: m6 with overheating of the engine that required replacement of the system.The console and motor were both replaced.No further information was provided.

Manufacturer Narrative

Section d10, g3, h4: additional information.Section d3, g2, h8: correction.Investigation conclusion: the reported event of a m6 alarm was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned to mcs zurich for analysis and was investigated.A log file was downloaded from the console for review.A review of the downloaded log file did not show the reported m6 alarm.The reported event was unable to be reproduced.The console was tested with the returned and associated motor (serial #: (b)(6)) reported in mfr # 2916596-2019-01259 and a test flow probe, loop, and monitor.The system ran at a speed of 4400 rpm with a flow of 5.5 lpm for 3 days.No errors occurred, and the console functioned as intended.The console was reprocessed to the repair and maintenance procedure (doc.# (b)(4), rev.04) and passed all tests (doc.# (b)(4)).The tested console was forwarded to the edc belgium.Although the reported event was not reproduced, reports of similar events have been documented.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (doc.# (b)(4), rev.09) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (doc.# (b)(4), rev.09) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (doc.# (b)(4), rev.07) has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (doc.# (b)(4), rev.09) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.The root cause for the m6 alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EMTEC PEDIATRIC FLOW PROBE, OUS
• Type of Device: PRIMARY CONSOLE WITH PEDIATRIC FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8484125
• MDR Text Key: 140950189
• Report Number: 2916596-2019-01258
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: 201-90701
• Device Catalogue Number: 201-90701
• Device Lot Number: 6361258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention