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

Model Number 102956

Device Problems Infusion or Flow Problem (2964); Excessive Heating (4030)

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

Event Date 08/09/2022

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

Related manufacturer report number: 3003306248-2022-12502 it was reported that there was an alarm on a centrimag for a patient on biventricular centrimag support.A emergency switch to the backup centrimag was performed.The customer reported an m6 alarm, motor over temperature.There was no flow to the patient during this event, but the patient was hemodynamically stable throughout.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a m6 alarm was not confirmed.The centrimag motor (serial#: (b)(6) was returned for analysis to the service depot and was evaluated and tested.The reported event of a m6 alarm and no flow was not confirmed.The motor was connected to a test loop and was run for several days.No alarm was observed.A functional checkout was performed and operated as intended.The root cause for the reported event was unable to be conclusively determined through this analysis.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 16 entitled ¿console alarms and alerts¿ addresses how to interpret and troubleshoot all system alarms including m6 alarms.The device history records were reviewed for the centrimag motor (serial#: (b)(6) and the motor was found to pass all manufacturing and qa specifications.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: 15322743
• MDR Text Key: 304696687
• Report Number: 3003306248-2022-12501
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Race: Black Or African American