MAUDE Adverse Event Report: Thoratec Switzerland GMBH CentriMag Blood Pump; Control, Pump Speed, Cardiopulmonary Bypass

Model Number	102953
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a motor failure on therapy.The centrimag pump was switched to backup motor and console.A "flow below minimum" alarm occurred while the patient's vital signs were deteriorating.Troubleshooting efforts included attempts to both increase and decrease the centrimag rpms; however, the 'flow below minimum' alarm continued to recur.Flow could not be achieved, and the reported flow decreased to 0.00 despite the centrimag continuing to run at approximately 2450 rpm.The pump was subsequently transferred to a backup motor and console.Following the exchange, flow did not immediately normalize; however, approximately two minutes later, flow returned after patient-focused interventions, including volume administration, repositioning, and sedation, were implemented.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: CentriMag Blood Pump
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50074190
• Report Number: 3003306248-2026-00260
• Device Sequence Number: 10216899
• Product Code: DWA
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 6 LB