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

Model Number 201-30300

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.Reporter address line 1: (b)(4).

Event Description

It was reported that the centrimag console suddenly made an abnormal "creaking" sound; the console had been supporting a patient for several weeks.The sound that was emitted was thought to be coming from the fan overheating or a malfunction of the cooling system.No alarms were reported along with the abnormal sound.The console was exchanged and would undergo preventative maintenance.There were no patient consequences.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console¿s (serial number: (b)(6)) cooling fan making a creaking sound was not confirmed, as the product was not returned for evaluation.Additionally, no log files were submitted for review.Provided information indicated that the unit was removed from service and being prepared to return to abbott for evaluation.Multiple attempts were made to obtain tracking information for the product¿s return; however, delays in customs were preventing the unit from being returned.If the console is received by abbott, this investigation will reopen to evaluate the product.The root cause of the reported event could not be conclusively determined via this analysis.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance (qa) specifications.The 2nd generation centrimag system operating manual (rev.M) section 4 entitled "warnings & 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." the 2nd generation centrimag system operating manual (rev.M) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an atypical ¿creaking¿ noise was not confirmed; however, damage that may have contributed to the event was confirmed.A log file was first extracted from the returned centrimag console (serial number: (b)(6)).The console was observed to be in patient use from 14:23 on (b)(6) 2023 to 8:31 on (b)(6) 2023.The speed and flow were recorded at ~3400 rpm and ~2.3 lpm respectively.The pump was disconnected at 8:31 on (b)(6) 2023 and the console was shut down a minute later, which is consistent with the provided information that the patient¿s care was switched to the backup console.The returned centrimag console was functionally tested at the service depot.During this testing, a few s3 alerts were produced due to an issue with the console¿s internal fan.The system was connected to a mock circulatory loop and was found to perform as intended despite the observed alert.Atypical noises were unable to be reproduced throughout testing.The console¿s housing was opened, and the unit was inspected at an internal level.A significant amount of dust was observed throughout the housing and around the console¿s fan assembly.The fan was replaced with a new component, and the interior of the console was thoroughly cleaned and vacuumed.The serviced and repaired console was then returned to the customer site after passing all tests per procedure.The fan assembly was forwarded to product performance engineering for further evaluation.Upon initial installation to a known working test console, the fan was not able to oscillate fully and was instead vibrating back and forth.However, upon powering down and restarting the console multiple times, the issue could not be reproduced again the fan was found to perform as intended.Although the reported ¿creaking¿ noise was not reproduced during testing, the dust buildup within the console and observed fan issue may have contributed to atypical sounds.The root cause of the reported event was suspected to be related to the damaged fan component; however, the reason for the fan issue could not be conclusively determined through this evaluation.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance (qa) specifications.The 2nd generation centrimag system operating manual (rev.M) section 4 entitled "warnings & 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." the 2nd generation centrimag system operating manual (rev.M) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.M) table 13 entitled ¿console alarms & alerts¿ states how to properly interpret and troubleshoot all system alarms including s3 alarms.No further information was provided.The manufacturer is closing the file on this event.

• 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: 16491450
• MDR Text Key: 311153086
• Report Number: 3003306248-2023-00760
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: 8885312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2011
• 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 Sex: Female