MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the centrimag motor was connected to the console and the pump was not rotating properly while sitting on the motor.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the blood pump not rotating correctly was confirmed via the log file.The centrimag motor (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review from the returned and associated centrimag 2nd generation primary console.A review of the downloaded log file showed events spanning approximately 6 days (14jul2022 ¿ 15jul2022, 20jul2022 ¿ 21jul2022, 08aug2022 - 09aug2022 per time stamp).The console was operating a motor at a speed of ~3700 rpm with a flow of ~4.00 lpm.On 15jul2022 at 18:40:38 a ¿flow below minimum: f3¿ alarm activated and at 18:40:40, the motor speed dropped to 0 rpm and the flow became a negative value.At 18:40:43, a ¿set pump speed not reached: m5¿ alarm activated which was followed by a ¿motor alarm: m4¿ at 18:40:53.At 18:41:19, an attempt to set the speed to 3700 rpm was made, but it was unsuccessful.At 18:41:21, a ¿motor stopped: m1¿ alarm activated and another attempt was made to set to speed and was unsuccessful.The motor was disconnected at 18:42:01 and the unit was powered off at 18:44:15.There were no other notable alarms active in the log file.The centrimag motor was returned for analysis to the service depot.The motor was connected to the returned and associated centrimag 2nd generation primary console and a mock loop for several days.During operation there were no alarms observed and it operated as intended.The reported event was unable to be duplicated.The motor was tested independently for several days and functioned as intended.The motor cable was manipulated during operation and no alarms were observed.The motor was functionally tested and passed all tests.Additional provided information communicated on 26jul2022 stated that there was no patient involved in this event.Additional provided information communicated on 03aug2022 stated that the event resolved by moving the pump to a new console and a new motor.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for centrimag motor (serial #: (b)(6)) and the motor was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual 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 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 table 16 entitled ¿console alarms and alerts¿ addresses how to interpret and troubleshoot all system alarms including m5, m4, m1, and f3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states that the battery needs to be replaced every 2 years.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• 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: 15158499
• MDR Text Key: 304961294
• Report Number: 3003306248-2022-12496
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• 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,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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