MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; Pump, blood, cardiopulmonary bypass, non-roller type

Device Problems Increased Pump Speed (1501); Pumping Stopped (1503)

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a while back, a patient was on support having a brief pump stop where the speed and flow both went to 0 simultaneously for a couple of seconds and then returned to baseline without intervention.Once it occurred twice on the patient, the motor, console, and flow probe were exchanged and sent for evaluation (which came back good).The same thing happened again this past weekend.The patient's speed and flow went to 0 for reportedly 6 seconds and then back to baseline.The nurse reported that the pump running sound disappeared as if it truly stopped during that time.It was noted that the patient had a pump exchange while on support on (b)(6) 2023 with oxygenator removal and that the nurses noticed that this pump was more ¿loose¿ than previous pumps.The patient was still on the same pump, but equipment had been changed when this happened previously.Related manufacturer reference number: mrn # 3003306248-2024-00002, 2916596-2024-00137.

• 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: 18465034
• MDR Text Key: 332891854
• Report Number: 3003306248-2024-00001
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2023
• 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 Age: 6 MO
• Patient Sex: Male
• Patient Weight: 5 KG