MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problems Overheating of Device (1437); Excessive Heating (4030)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that a hospital requested that emergency care research institute (ecri) test a centrimag system.The following morning after the system was run overnight using a centrimag training circuit loop, the system was found at 0 rpm and alarming for motor over temperature.An infrared thermometer was used, and the motor surface temperature was measured to be 200f.A review of the datalogger data showed that the alarm was initiated around 6 hours earlier at which time an automatic motor shutdown was initiated.Despite the motor shutdown, power was thought to have continued to be delivered to the motor as it would have cooled to ambient temperature otherwise.Subsequently, ecri ran the system for three, five-day continuous runs with no stoppages and no overheating episodes.Temperature monitoring of the circulating water revealed that heat from the motor transferred to the disposable circuit.The ecri problem reporting system hazard reporting reported that the pump motor could spontaneously become hot enough to damage blood.Related manufacturer reference number: 3003306248-2024-00428 (centrimag motor) related manufacturer reference number: 2916596-2024-01171 (centrimag pump).

Manufacturer Narrative

A1-a4: there was no patient involvement.B5: the event date was estimated.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18759870
• MDR Text Key: 336984983
• Report Number: 3003306248-2024-00429
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• 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