MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560BCS1

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia (1942); Cardiovascular Insufficiency (4445)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this bio-console instrument the backup battery was unreliable and the power output time did not match the nominal power in the manual.Due to acute large-area myocardial infarction, the patient needed to use ecmo to replace the heart function in order to be transferred from the other hospital to this hospital for treatment.The ecmo team at the facility received a request from (b)(6) hospital to implement ecmo treatment on the afternoon of march 21.The team members set out after checking the materials and equipment.At 20:00, the pre-inflation was completed when the instrument was using ac power, and the reserve battery showed green full power.At 20:30, the patient's arteriovenous cannula insertion was completed, and then the patient was successfully connected and the instrument started to turn.The centrifugal pump speed was set to 2730 r/min and the flow rate was 2.93l/min.After observation for a period of time, the patient¿s vital signs met the requirements for transfer, the ac power was disconnected at 20:58, the reserve power was activated, and battery display was full.The team members worked in cooperation with a due division of labor to carry the patient and equipment to the ambulance on standby downstairs, at approximately 21:05, it was found that the reserve power was yellow with 8 cells, and it was prompted that the power was insufficient.After that, the power dropped rapidly.Before the transfer to the ambulance at 21:13, there was only one cell on the battery icon, and then it was automatically turned off.The patient¿s heart rate dropped from the original 110 beats/min to heart rate 75 beats/min, blood oxygen saturation dropped from the original 98% to 88%.The medical staff immediately removed the centrifugal pump head and replaced it with the hand pump and manually maintained the centrifugation pump.After rescue, the patient¿s vital signs improved, with heart rate 95 beats/min, blood pressure 95/52mmhg, blood oxygen saturation 95%.After that, the equipment and the patient were loaded into the ambulance with the use of a hand pump, and the ac power on the ambulance was connected.After the ecmo was able to operate normally, they returned to the hospital immediately.They arrived at this hospital at 22:00, and after the patient and the equipment were removed from the ambulance, the power of ecmo equipment was still insufficient to reach the department.After they entered the elevator, it had been maintained by a hand pump.The ecmo could not be connected to ac power until the patient reached the catheterization room.The operation was successfully completed and the patient returned to the ward.

Manufacturer Narrative

Device evaluation summary: the reported battery issue was verified during service.The issue was resolved by replacing the main pcb and battery.Post-repair testing was performed per specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient code updated.There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: the product analysis information that was previously submitted for this event belonged to another event which had occurred for this bio-console instrument.Annex e, annex b and annex c have been corrected as well.The initial reporter occupation and phone number have been corrected in section e.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: BIO CONSOLE 560
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12324137
• MDR Text Key: 266635932
• Report Number: 2184009-2021-00070
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000236526
• UDI-Public: 00763000236526
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 53 KG