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

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event date has been estimated.It was reported that the centrimag console displayed a b1 (battery module failure) alarm.The battery had last been changed in (b)(6) 2021.There were no adverse patient consequences.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console displaying a b1 alarm was confirmed.A log file was downloaded from the returned centrimag console.A review of the downloaded log file showed events spanning approximately 48 days (06jan22 ¿ 11jan22, 14jan22, 17jan22 ¿ 19jan22, 24jan22 ¿ 25jan22, 30jan22 ¿ 05feb22, 30mar22, 05apr22 ¿ 08apr22, 10apr22 ¿ 11apr22, 13apr22, 18apr22 ¿ 22apr22, 02may22 ¿ 06may22, 16may22 ¿ 17may22, 26may22, 30may22 ¿ 01jun22, 06jun22, 10jun22, 15jun22, 17jun22, 01sep22 per time stamp).Events occurring on 01sep22 took place during testing at abbott.The system was powered on at 13:00 on 06jun22.Immediately following startup ¿battery module fail:b1¿ alarms were active.The b1 alarms were active on 06jun22 at 13:00, 13:12, 13:13, 13:21, 13:33, 16:09, 16:11, 10jun22 at 10:44, 15jun22 at 08:45, 14:44, and 14:45, and 17jun22 at 13:51.There were no other notable events active in the log file.Pump operation was not affected.The returned centrimag console, serial l01940-0001, was evaluated at the edc.The returned console¿s battery cable between the charger pcb and battery was not connected properly.The battery cable was connected and the console was tested with known working test centrimag equipment.The unit booted up and functioned as intended.There was a b6 alarm active but that alarms per design when operating on battery power.A full functional checkout was performed and the unit passed all tests.The unit was sent back to the customer.A root cause for the reported b1 alarm was due to the battery cable connector being loose; however, a root cause for the loose connector was not conclusively determined.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: l01940-0001) and the console was found to pass all manufacturing and quality assurance (qa) specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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.L) table 13 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including b1 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: 14831718
• MDR Text Key: 303278540
• Report Number: 3003306248-2022-11290
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2012
• 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