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

Model Number 201-90411

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device-10 days.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that patient was started on extracorporeal membrane oxygenation (ecmo) on (b)(6) 2019.Patient was in icu room when cmag console alarmed.When the speed was set to 0 rpm, negative flow was observed.No intervention effective when trying to increase speed on console screen.Speed returned to initial settings spontaneously.Event re-occurred within minutes and console and motor were exchanged.The backup console also went down.Products were returned.

Manufacturer Narrative

Section h4: additional information.Investigation summary: the report of negative flow being captured when pump speed was set to 0lpm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.Per the log file, the console was powered up at ~9:10am on july 4, 2019 and ~1 minute later pump support was started at a set speed of 5500rpm and a flow remained in the ~4.5lpm - 5.0lpm range.At ~12:59pm the pump was stopped due to a user request and the speed reading was 0rpm.During this time flow was briefly in the -0.007lpm to -0.002lpm range.These values did not indicate an issue with the system but appeared to confirm the reported event.The console was powered down at ~1:01pm.No additional events were captured on the reported event date of (b)(6) 2019.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot.The complaint could not be duplicated during their evaluation.The console ran with its associated motor and flow probe.The console operated for an extended period of time and no issues were observed.No alarms nor any flow problems were detected.However, it was noted that the console's battery had expired on july 31, 2019.This was noted to be an additional observation that could not be correlated to the reported event.The battery was replaced with a new one free of charge and battery maintenance was performed successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.As a result, the root cause of the reported event could not be correlated to a console related issue.The serviced and tested console was returned to the customer site.Per the centrimag 2nd gen system operating manual 'the flow probes can detect retrograde flow.Retrograde flow of up to 2.0 lpm is displayed as a negative number such as ¿-0.65 lpm¿.Retrograde flow greater than 2.0 lpm is displayed as downward arrows ¿vv.Vv lpm¿.A disconnected or malfunctioning probe will display dashes ¿--.--¿.If the probe detects forward flow of more than 10 lpm then it will display as ¿^^.^^ lpm¿'.Retrograde flow does not necessarily indicate a functional issue with the system but can be caused by patient condition, cannula placement, or manipulation of the flow circuit.Reports of similar issues will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on the event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8826353
• MDR Text Key: 152189216
• Report Number: 2916596-2019-03359
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 74