MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS

Model Number 201-10002

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 motor l00344-0011.Primary console l00934-0008 is reported under medwatch mfr report # 2916596-2019-00945, primary console l00934-0009 is reported under medwatch mfr report # 2916596-2019-00946, and motor l00569-0011 is reported under medwatch mfr report # 2916596-2019-00948.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 (l00934-0008) alarmed and displayed "----" for the flow reading.The flow probe was repositioned with no success.The primary console was exchanged to the backup console (l00934-0009).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

The reported event of blank flow was confirmed, and a motor disconnected: m2 error was observed.The centrimag motor was returned to ppe for analysis.The motor cable failed resistance testing at the connections ux/uy, hx/hy, i2c scl/i2c sda, and agnd/5v when the motor cable was manipulated at the motor end.The motor cable failed insulation testing at b1+/b1- when tested against agnd.The centrimag motor was then returned to the service depot for analysis.The returned centrimag motor was evaluated and tested under work order #(b)(4).The service depot was able to confirm and duplicate the reported event of blank flow.The motor immediately produced a m2, motor disconnected, error, confirming ppes resistance test and failed cable breakdown test.The root cause for the reported event and the observed m2 error was conclusively determined to be due to damage to the motor cable.No further information was provided.The manufacturer is closing the file on the event.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8415166
• MDR Text Key: 138661468
• Report Number: 2916596-2019-00949
• Device Sequence Number: 1
• Product Code: KFM
• 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: 05/31/2019

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: 201-10002
• Device Catalogue Number: 201-10002
• 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: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention