MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC THIN WALLED PEDIATRIC FLOW PROBE; Control, pump speed, cardiopulmonary bypass

Model Number 201-30109

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/27/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

• Brand Name: EM-TEC THIN WALLED 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: 18915429
• MDR Text Key: 337800890
• Report Number: 3003306248-2024-00440
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140115
• UDI-Public: 07640135140115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1