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

Model Number 201-90411

Device Problems Failure to Charge (1085); Electrical /Electronic Property Problem (1198)

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

Event Date 06/09/2023

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 centrimag/pedimag console was alarming stating that a battery was below the minimum charge, while plugged directly to a red outlet in the pediatric operating room.Other console plugged into the same red outlet was fine, no issues.A battery test was run on both consoles and batteries and both passed.The same console was observed for two weeks, and battery seemed to only charge to 4 hours then began to blink green on the battery icon, indicating it was trying to charge the battery once turned on.The problem did not resolve, so the console was removed from use.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the centrimag console (serial number: (b)(6) producing a b2 battery below minimum alert and being unable to charge its battery (serial number: (b)(6) to full capacity were not confirmed.Both the console and battery were returned to the pleasanton service center in unremarkable physical condition.Battery maintenance was performed three consecutive times; each time, the battery passed, and no atypical events were observed.The console was connected to a test loop and allowed to run for several days.The battery¿s charge was monitored and remained stable throughout testing.The unit passed a full functional test and was then returned to the customer.The downloaded log file captured the console being in patient use from 4:16 to 18:31 on 14apr2023.The pump appeared to operate with steady flow of 0.25 - 0.3 liters per minute (lpm) and steady speeds of 2000 - 3000 revolutions per minute (rpm).The console was powered on several more times, but a pump was not connected.From 18:15 20apr2023 to 19:03 21apr2023, battery maintenance was performed.During this testing, b5 low battery and b2 battery below minimum alerts were observed; however, these are normal features of the battery depletion that occurs during the maintenance process.No other battery-related alerts were observed.Outside of the window of battery maintenance, the battery capacity and expected battery runtime had values within normal ranges.The expected runtime of the battery depends on the set motor speed and flow level and as mentioned in the 2nd generation centrimag system operating manual, may be decreased if monitor is connected during battery operation.The root cause of the reported events could not be conclusively determined via this analysis.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6) and the console was found to pass all manufacturing and quality assurance specifications.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 7.24 entitled ¿monitor connection¿ cautions that operating the monitor while on battery support will shorten the battery runtime.The 2nd generation centrimag system operating manual (rev.M) section 8.4 entitled ¿battery operation¿ warns the user that once a low battery alert is displayed, ac power must be restored as quickly as possible.It is also noted that if the console is operating on batteries and a battery below minimum alarm is displayed, the pump could stop at any time without further warning.The user is instructed to operate the system at the lowest acceptable clinical flows when on battery power, so that the remaining battery time can be conserved.The 2nd generation centrimag system operating manual (rev.M) section 8.5 entitled ¿operation of the centrimagtm circulatory support system on internal console battery power¿ provides approximate console runtimes when operating on internal battery power.The 2nd generation centrimag system operating manual (rev.M) table 6 describes the way that power source and battery time remaining data is displayed on the console¿s front panel.It is noted that if the battery light is flashing, the battery is charging.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 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: 17210842
• MDR Text Key: 317968351
• Report Number: 3003306248-2023-01951
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• 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: 07/28/2023

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
• Device Catalogue Number: 201-90411
• Device Lot Number: 8590208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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