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

Model Number 560

Device Problems Mechanical Problem (1384); Material Deformation (2976); Power Problem (3010)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: during preventive maintenance by a service technician it was noted this bio-console instrument displayed an error message (power failure) although the instrument was always connected to the mains.The service technician noted that when the motor speed was increased a message came up with ac power failure and they observed that the output voltage of the power supply was out of specification and it could not be adjusted (26.7v and drops down with a motor speed into 22.8v).A pressure leakage was observed in channel 1 and 2 and they observed a broken blind connector inside the base unit of the instrument.The issues were resolved by replacing the power supply ), blind connector, motor / pressure board and hw screw ph ss pf 1/2 and performing a technical services updated to update the user interface (ui) software to version 2.U02.010.Preventive maintenance was completed per specifications.Conclusion: complaint confirmed.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.

Event Description

During preventive maintenance by a service technician it was noted this bio-console instrument displayed an error message (power failure) although the instrument was always connected to the mains.The service technician noted that when the motor speed was increased a message came up with ac power failure and they observed that the output voltage of the power supply was out of specification and it could not be adjusted (26.7v and drops down with a motor speed into 22.8v).A pressure leakage was observed in channel 1 and 2 and they observed a broken blind connector inside the base unit of the instrument.This was detected during service so there was no adverse patient effect.

• Brand Name: BIO-CONSOLE
• 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: 16918856
• MDR Text Key: 315083685
• Report Number: 2184009-2023-00257
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/12/2023

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: 560
• Device Catalogue Number: 560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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