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

Model Number 102956

Device Problems Loose or Intermittent Connection (1371); Failure to Power Up (1476)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on two separate occasions the centrimag console showed 0 rpms after normal movement of the motor.The first time this occurred the cooling fan bumped against the motor cord, and the second time the motor cord was bumped while reaching for the flow probe.The second of the two events occurred on 2jun2021 at 7:15.When the console showed 0 rpm, the motor was confirmed to not be running by touch.Flow also dropped to 0 rpm.After about 8-10 seconds the console read the previously programmed rpm and flow returned.The motor was spinning with no irregular turbulence at that point.The choice was made to exchange the console and motor that were in use on the patient.The issue was determined to be caused by the cord not being 100% engaged to the back of the console, resulting in a faulty connection.The events resolved after the console and motor were exchanged and they would not be sent back for evaluation.Related manufacturer report number of console: 3003306248-2021-02977.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console showing 0 rpm and the motor not running was not confirmed.The centrimag motor (serial #: (b)(6)) was not returned for analysis.Additional provided information communicated on 11jun2021 stated that the item will not be returned for analysis.The device will continue to be monitored in-house going forward.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag motor 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 section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.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
• MDR Report Key: 12104198
• MDR Text Key: 268236542
• Report Number: 3003306248-2021-02976
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 103