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

Model Number 201-30300

Device Problem Unable to Obtain Readings (1516)

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

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is reporting primary console (b)(4).Primary console (b)(4) is reported under medwatch mfr report # 2916596-2019-00945, motor (b)(4) is reported under medwatch mfr report # 2916596-2019-00948, and motor (b)(4) is reported under medwatch mfr report # 2916596-2019-00949.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 membrane oxygenation (ecmo) support.It was reported that during patient transport between (b)(6) hospital to (b)(6) hospital, the primary console ((b)(4)) alarmed and displayed "----" for the flow reading.The flow probe was repositioned with no success.The primary console was exchanged to the backup console ((b)(4)).After approximately 10 minutes, the flow displayed ¿----¿.Despite repositioning the flow probe and switching the console off and on, the fault would not resolve.The healthcare professional relied on oxygen saturation levels, pressures, etc.As indicators of adequate flow, and the rest of the transport was uneventful from this respect.It was reported that when the flow probes, etc.Were being adjusted, the healthcare professional could feel an electrical tingling sensation when in contact with the cart and some of its components.On arrival at the hospital, the crew disconnected the trolley from the ambulance dc supply and moved the patient directly to the ct scanner.It was reported that the healthcare professional did not notice any action which could lead to cable damage.A flow probe from (b)(6) hospital was connected, but this still failed to register a flow so it was assumed that the fault was in the console.The patient was transferred to (b)(6) ecmo device, which immediately displayed the expected flow of approximately 4 l/min.No additional information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: the centrimag 2nd generation primary console was returned to the service depot for analysis.The returned console was evaluated and tested under work order #(b)(4).The service depot was unable to confirm or duplicate the reported blank flow.The console was tested with the associated motor and flow probe.The console performed as intended and there were no disruptions in the set rpms or flow speeds at any point.No dashes were observed in the lpm reading either.A full functional checkout was performed, and the unit passed all tests.A log file was extracted from the system for analysis.A review of the log file showed data spanning approximately 202 days ((b)(6) 2018 ¿ (b)(6) 2019 per time stamp).On (b)(6) 2018 at 15:31, the ¿tech: flow error¿ ¿can bus send error¿ and the sub fault ¿sf_flow_other¿ occurred triggering a ¿system alert: s3¿.The ¿system alert: s3¿ was able to be muted.At 15:32, the flow dropped to 0 lpm and was coincident with the sub fault ¿sf_flow_low_amplitude¿ and the fault ¿flow signal interrupted: f2¿.The console was turned off and on again at 15:32; however, the flow remained at 0 lpm and the ¿tech: flow error¿ ¿can bus send error¿ remained active.No further information was provided.The manufacturer is closing the file on this 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: 8415152
• MDR Text Key: 138693363
• Report Number: 2916596-2019-00946
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention