MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

This event occurred at (b)(6).Manufacturer's investigation conclusion: the reported event of the em-tec adult flow probe not measuring flow through the extracorporeal membrane oxygenation (ecmo) circuit was confirmed via analysis of the returned unit.The flow probe serial number (b)(4) was returned and evaluated at abbott (b)(4).During the evaluation, the flow probe was connected to a known working test fixture and the reported event was confirmed when the flow probe was not measuring any flow.An f2 (flow signal interrupted) fault code was active during this time.A continuity test was performed on the underlying wires of the cable to reveal that the white (+5v) underlying wire contained an open loop resistance, indicating a break in the underlying conductor.All other wires contained similar resistances and were operating as intended.Additionally, the cable was dissected to reveal a severe kink in the white underlying wire and a damaged conductor.Provided information stated that according to the hospital team the flow probe was not measuring flow through ecmo circuit, there were no flow alarms, and the product will be returning for analysis.The root cause of the reported event was determined to be wire fatigue in the white underlying wire of flow probe cable, causing the flow probe to not measure any flow; however, the root cause of the damage to the wire could not be determined through this analysis.There were incidental findings of other kinked underlying wires that did not affect the functionality of the cable.Review of the device history record for the centrimag flow probe, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 8.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 section 10.1 entitled "appendix i-2nd generation centrimag primary console alarms and alerts" contains a list of console alarms and alerts, including s3, m2, and f2 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the flow probe did not work.The flow probe was not measuring flow through the extracorporeal membrane oxygenation (ecmo) circuit.No flow alarms were active.There was no patient involved.

• Brand Name: EM-TEC ADULT FLOW PROBE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15103907
• MDR Text Key: 304804627
• Report Number: 3003306248-2022-12492
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 07640135140108
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2022

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: 201-30105
• Device Catalogue Number: 201-30105
• Device Lot Number: 7226430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1