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

Model Number 201-30107

Device Problems Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the screen showed no flow.The patient went into arrest and advanced resuscitation maneuvers were initiated, as well as high inotropic support.They performed an emergency change; they went to the backup motor and backup console.Flow was reestablished and the patient came out of arrest.It was noted that the patient had been on extracorporeal membrane oxygenation (ecmo) support since (b)(6) 2023 for tracheoesophageal fistula/acute respiratory distress syndrome (ards).The patient was hemodynamically stable.Related manufacturer reference number: 2916596-2024-00789 (centrimag console).Related manufacturer reference number: 3003306248-2024-00407 (centrimag motor).Related manufacturer reference number: 3003306248-2024-00408 (centrimag blood pump).

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: EM-TEC PEDIATRIC 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18725743
• MDR Text Key: 335709811
• Report Number: 3003306248-2024-00409
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140115
• UDI-Public: 07640135140115
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 3 MO
• Patient Sex: Female