MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH; Ventricular (Assist) Bypass

Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
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 while the patient was on extracorporeal membrane oxygenation (ecmo), the pump continually triggered flow below minimal level alarm.There was no change in flow on the screen or the red flow indicator bar.The only noticeable change was what looked like a slight suction event on the linear trace on screen.Once off of ecmo and clamped off to the patient, circulating through the arterial venous bridge, the low flow as well as the maximum flow alarm continued to alarm, with no noticeable change on screen.The patient was isolated from the circuit and flow through the bridge was approximately 300ml/min.There were slight concerns of a possible issue with equipment as the healthcare provider could visibly watch the alarm trigger every 10 minutes with no change in flow or pressure on screen.
Additional Manufacturer Narrative
A.Patient information was not provided by the customer.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
The alarm had been consistently present and alerted for flow exceeding the maximum or minimum threshold.While the alarm was present, the flow value displayed on the monitor was not changing.However, the trace at the bottom of the display showed spikes and dips.The fault was persistent even after the patient was disconnected and the clinical staff used a closed circuit.The blue locking mechanism was not working either.Additional information was received that the motors were not swapped and the system was not retested after the fault occurred.

• Common Device Name: Ventricular (Assist) 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24148368
• Report Number: 3003306248-2026-00032
• Device Sequence Number: 12983541
• Product Code: DSQ
• UDI-Device Identifier: 07640135140627
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/23/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 07/17/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/01/2026; 07/27/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown