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

Model Number	201-30109
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient, who was on a pedimag, had suction events on the evening on (b)(6) 2023.No alarms were triggered.Log files were submitted for review and captured a low flow event showing a drop to 0 liters per minute (lpm), associated with a loss of flow signal.The event was muted or cleared within 5 seconds.The flow dropped to approximately 1.0 lpm (lowest value recorded was 0.9 lpm.) this did not result in an alarm because the alarm threshold was set to 0.5 lpm at the time.There was another low flow showing 0 lpm, again associated with a loss of flow signal.This alarm was also muted/cleared.Again, there was another low flow showing 0 lpm, again associated with a loss of flow signal, which was also muted/cleared.Related manufacturer reference number: 3003306248-2024-00442, 3003306248-2024-00439, 3003306248-2024-00441.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
D2b: device product code corrected.H5/h8: usage corrected.Manufacturer¿s investigation conclusion: the reported event of flow-related alarms was confirmed via the provided log file.The log file contained data spanning approximately 8 days ((b)(6) 2024 per timestamp).The system was operating around the set speed on the reported event date of (b)(6) 2024.A few f2: flow signal interrupted alarms were intermittently observed throughout the data, temporarily displaying the patient¿s flow value as 0 lpm.These alarms were muted and cleared within a few seconds of activation, restoring the patient¿s flow values to expected values.Although it was unable to be conclusively determined from the log file alone, these alarms could have correlated to the reported suction events.No other notable events were observed.The centrimag flow probe (serial number unknown) was not returned for analysis.Questions regarding the flow probe and the event were asked multiple times and no responses were received.The root cause of the reported event was unable to be conclusively determined through this analysis.The centrimag flow probe¿s serial number was not provided.The 2nd generation centrimag system operating manual section 4 "warnings and 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 12.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow-related alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: EM-TEC THIN WALLED 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: 18915429
• Report Number: 3003306248-2024-00440
• Device Sequence Number: 3568944
• Product Code: QNR
• UDI-Device Identifier: 07640135140115
• UDI-Public: 07640135140115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 201-30109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 07/09/2024
• 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
• Patient Sex: Unknown