MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 106524

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  Injury  

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 the patient was already on extracorporeal membrane oxygenation (ecmo) switched to biventricular assist device (bivad) support in the operating room (or).Approximately 10 minutes after switching to bivad, the generation 1 screen on the left ventricular assist device (lvad) started blinking on and off.After about 2-3 minutes the screen remained off.The charging light and pump remained on during the event.After switching to a second pump the battery maintenance required alarm appeared, which prompted the perfusionist to change pumps again before leaving operating room.Related manufacturer report number: 2916596-2022-11267.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a battery maintenance required alarm was not confirmed.The centrimag 1st generation primary console serial #: (b)(6) was not returned for analysis.Additional provided information communicated on 23jun2022 stated that the events did not resolve.The centrimags were exchanged for other centrimags.The patient was taken off support which this exchanged happened briefly.No product will be returned for analysis.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 1st generation primary console serial #: (b)(6) and the console was found to pass all manufacturing and qa specifications.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, 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 primary console or primary motor experience a malfunction." centrimag primary console operating manual table 13 entitled ¿console alarms & alerts¿ states in response to a b4 alarm, ¿do not se the console.Perform battery maintenance according to the instructions in section 9.4¿ section 9.4 details how to perform battery maintenance and how often.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the event did not resolve.The centrimags were exchanged out for other centrimags.The patient was taken off support while this exchange happened briefly.No products would be returned.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14549922
• MDR Text Key: 293078288
• Report Number: 2916596-2022-11268
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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 Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic