MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION ADULT FLOW PROBE ¿ 3/8¿; CARDIOPULMONARY BYPASS

Model Number	102957
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the centrimag began to have low flow alarms with a flow of 0 lpm with no precipitating event and no accompanying chattering visualized in the drainage tubing.Despite adjustment of the speed, and exchanging of the flow probe, flow above 0 liters per minute (lpm) was unable to be achieved.It was decided by the care team to exchange the blood pump due to the concern that a clot was causing the impedance in flow.After exchanging to a new centrimag blood pump, flow above 0 lpm was still unable to be achieved.Assessment of the tubing most proximal to the patient was done and separation of blood and plasma was visualized.The patient was started on an inotrope (dobutamine), centrimag support was stopped, and the patient was de-cannulated due to presumed clotting of the single-site double lumen cannula inserted in the right internal jugular vein.Prior to the event, patient was systemically anticoagulated and within a therapeutic range.Duration of event was approximately 20 minutes.Due to hemodynamic stability, the patient was not re-cannulated, and support was not resumed at that time.Additionally, the care team further assessed and flushed the original centrimag blood pump and noted there to be no clots formed inside the blood pump.25000u of heparin was given intravenous push throughout the process.Patient remained in the intensive care unit, stable and awaiting heart transplant.Related regulatory reference report mfr # 3003306248-2023-07171; 3003306248-2023-07170;.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was additionally reported that the thrombus was identified in the protek duo cannula that was used.The patient was stable.
Additional Manufacturer Narrative
Section a4: patient weight was requested but was not provided.Section d4: serial number was requested but was not provided.Manufacturer's investigation conclusion: the centrimag flow probe, serial number unknown, was evaluated due to the reported event of the centrimag system alarming with a low flow alert and displaying 0 lpm for the flow value.Per additional information, thrombus was identified in the cannula that was used which caused the event to occur, and no issues regarding the centrimag flow probe were reported.No products were returned for analysis, no log files were associated with the reported event, and the patient¿s status was stated to be stable.The reported thrombus will be addressed via the centrimag blood pump¿s investigation.The serial number of the centrimag flow probe was not provided.The 2nd generation centrimag system operating manual (rev.M, 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." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION ADULT FLOW PROBE ¿ 3/8¿
• Common Device Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17987364
• Report Number: 3003306248-2023-07169
• Device Sequence Number: 18192450
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 7640135140108
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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): 01/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 102957
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/11/2024
• 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 Age: 53 YR
• Patient Sex: Female