MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; Control, pump speed, cardiopulmonary bypass

Model Number 201-90411

Device Problems No Audible Alarm (1019); Infusion or Flow Problem (2964)

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

Event Date 01/07/2024

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 the patient was on biventricular assist device with centrimag implants.The left ventricular assist device support console did not have an audible alarm for a minimum flow alert.Additional information was provided that a minimum flow alert did alarm as intended at first which was acknowledged by the registered nurse and then silenced.Per the site, the console should have re-alarmed after the minute "mute" if the alert wasn't resolved and it did not.The yellow flow below minimum banner remained on the screen, and then flow remained below the minimum flow limit for greater than 10 minutes without alarming.Additional information was provided that the cause of the low flow alarms was due to suction events/hypovolemia.It resolved after approximately 10 minutes.No changes to hemodynamics were reported and the patient remained stable through the time of the event.No products were exchanged, the patient remained on support.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18646810
• MDR Text Key: 334649563
• Report Number: 3003306248-2024-00401
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• 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
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 22 KG