MAUDE Adverse Event Report: PERFUSION SYSTEMS CONSOLE R560BCS1 REFURB CONTROLLER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number R560BCS1

Device Problems Power Problem (3010); Pressure Problem (3012)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

During preventive maintenance by a service technician this bio-console 560 instrument's power supply voltage was fluctuating between 26vdc-29vdc and the instrument failed the pressure leak test.The initial problem was the fluctuating power supply voltage.Once that was repaired, the technician conducted further testing of the device and started the leak test, a 1000mmhg pressure was injected into the bp ports to maintain a pressure for a long period of time.The pressure board did not hold pressure, which indicates a leak in the system.This was detected during service so there was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

Device evaluation summary: during preventive maintenance a by service technician it was observed that the power supply voltage was fluctuating between 26vdc-29vdc and the instrument had failed a pressure leak test.The issues were resolved by replacing the power supply and m/p module pwa and performing pressure and power supply calibration.Preventive maintenance was completed 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

Conclusion: the complaint was confirmed for the bio-console instrument's fluctuating power supply voltage and failed pressure leak test.The issue was identified during preventive maintenance and resolved by replacing the power supply and m/p module.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Trends for issues with this instrument are monitored.Correction h2 label for single use: this field has been updated to no.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.

• Brand Name: CONSOLE R560BCS1 REFURB CONTROLLER
• Type of Device: OXYGENATOR, 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: 14683551
• MDR Text Key: 301985503
• Report Number: 2184009-2022-00136
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00613994450319
• UDI-Public: 00613994450319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R560BCS1
• Device Catalogue Number: R560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2011
• 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