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

Model Number 201-90411

Device Problems Disconnection (1171); Unexpected Shutdown (4019)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477); Respiratory Insufficiency (4462)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer report numbers: 3003306248-2022-14505, 3003306248-2022-14506 and 3003306248-2022-14507.It was reported that while the patient was being moved from one bed to another on full centrimag support with no prior equipment issues or malfunctions, the console power cable was unplugged and the entire system shut down.The power cable had been plugged into the patient's bed and not into the ac wall power.The team began the procedure to switch to back up equipment.They stated the backup equipment would not turn on initially either.It was also plugged into the patient's bed and not to ac power.Eventually, they were able to place the patient on backup equipment.During this time, the patient required bag ventilation.The patient's blood oxygen saturation was reported to be approximately 70-79%.No inotropes or other interventions were initiated.The team stated there was no alarm.The system "just shut off completely.".

Manufacturer Narrative

Section d4: expiration date incorrectly provided in previous report.Expiration date is not applicable for centrimag 2nd generation primary console.Manufacturer's investigation conclusion.The reported event of the centrimag 2nd generation primary console shutting down after being unplugged without the internal battery support was not confirmed.The centrimag 2nd generation primary console (serial number (b)(6) and the internal battery (serial number (b)(6) was not returned for analysis, and there were no log files or any other supporting documents submitted that would indicate an issue with the console.It was reported that while the patient was being moved from one bed to another on full centrimag support with no prior equipment issues or malfunctions, the customer accidentally unplugged the power cable of the console after which the entire system shut down.Per the device history record of the console, the internal battery inside the console was expired on 28feb2019, indicating that the battery was expired on the date of the reported event (13oct2022).An expired battery could cause the internal battery to not hold a charge and support the system and pump function.Per the 2nd generation centrimag system operating manual, the console is designed for operation on ac power; however, it also contains an internal rechargeable battery and charger.If a power failure causes loss of ac power or patient transport is necessary, a new fully charged internal battery will operate the console for approximately 120 minutes at 5.5 lpm and 3,500 rpm when used with the centrimag pump and approximately 180 minutes at 1.0 lpm and 3,000 rpm when used with the pedimag pump.Provided information stated that the console serial number is (b)(6).Multiple attempts were made to obtain additional information from the customer regarding the tracking information; however, no additional information was provided.The products are assumed to not be returning to abbott.If the products return, the investigations will reopen.The root cause of the reported event could not be conclusively determined through this analysis; however, the internal battery not providing support due to it being expired could have contributed to the reported event.Review of the device history record for the centrimag 2nd generation primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual, rev.M, section 4 "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 8 "system operation" states that the console is designed for operation on ac power; however, it also contains an internal rechargeable battery and charger.If a power failure causes loss of ac power or patient transport is necessary, a new fully charged internal battery will operate the console for approximately 120 minutes at 5.5 lpm and 3,500 rpm when used with the centrimag pump and approximately 180 minutes at 1.0 lpm and 3,000 rpm when used with thepedimag pump.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: 15714403
• MDR Text Key: 302843622
• Report Number: 3003306248-2022-12529
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5864810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White