MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2023

Event Type  Death  

Manufacturer Narrative

This information was previously reported under mfr # 3003306248-2023-05043.H6 - health effect - clinical code: 4868 - hemodynamic instability.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag screen read 0 rotations per minute (rpm) and 0.00 liters per minute (lpm).The nurse attempted to switch the flow probe to see if it was malfunctioning.The patient became hemodynamically unstable with their stats in the 20s requiring bagging, no cardiopulmonary resuscitation (cpr).An emergency console and motor exchange was performed.Care was withdrawn due to futility of care on (b)(6) 2023 at 1054 and the patient passed away.A training loop was performed to recreate the event to see what alarms, if any, were to occur but the alarms were not replicated.Venovenous extracorporeal membrane oxygenation (vv ecmo) was initiated on (b)(6) 2023 with no modifications or circuit changes.Related mfr # for the centrimag motor: mfr # 3003306248-2023-05043 and related mfr # for the centrimag console: mfr # 3003306248-2023-05044.

Manufacturer Narrative

H6 - health effect - clinical code: 4868 - hemodynamic instability.Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported event and subsequent patient outcome could not be conclusively determined through this evaluation.The device was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) are currently available and list death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events¿.Ifu warning #9: potential risk to the patient should be evaluated prior to changing a pump.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18183179
• MDR Text Key: 328686067
• Report Number: 3003306248-2023-07181
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 65 KG