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

Model Number	201-30107
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem 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).
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the flow probe (serial number: (b)(6)) is being evaluated for system alarms.The flow probe was not returned for analysis; however, a log file was downloaded for review.A review of the downloaded log files showed events spanning approximately 3 days ((b)(6) 2024 per timestamp).Events captured on (b)(6) 2024 took place at abbott.A system shutdown was initiated on (b)(6) 2024 at 03:05 and s3 and m4 motor alarms activated shortly after.The console was shut down on (b)(6) 2024 at 03:12 and the alarms cleared after the console was restarted.There were no other notable alarms active in the log file.There were no issues reported with the flow probe.The device history records were reviewed for the flow probe (serial number: (b)(6)) and was found to pass all manufacturing and qa specifications before being shipped to the customer.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1 ¿appendix i ¿ console alarms and alerts¿ table 16 details how to properly interpret and troubleshoot all system alarms including s3 and m4 alarms.No further information was provided.The manufacturer is closing the file on this event.
Additional 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
• Common Device Name: 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
• Report Number: 3003306248-2024-00409
• Device Sequence Number: 12346426
• Product Code: DWA
• UDI-Device Identifier: 07640135140115
• UDI-Public: 07640135140115
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 201-30107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 08/09/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/30/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 3 MO
• Patient Sex: Female