MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-CONSOLE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number R95180

Device Problems Battery Problem (2885); Material Deformation (2976)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Medtronic received information that at an unspecified time this bio-console base instrument required repair due to an unspecified issue.Use of the instrument was unspecified and there was no resulting adverse patient effect.

Manufacturer Narrative

Device evaluation summary: the reported need for repair was verified during service.Technician observed battery indicator displayed depleted and after power off and on it displayed fully charged.Cover and bezel broken from switch.Observed cracked in the start/stop timer buttons on the graphic label of the console.Liquid could run through it.Elapsed time: 1879 hours.Observed error 3 in the log files.Centrifuge speed was within calibration but the motor appeared to be weak.The instrument was scrapped as medtronic no longer service or support this system.This included preventative maintenance, per incident repair, and technical support.Conclusion: complaint confirmed for reported need for repair was verified during service.Medtronic service sent end of life letter to customer indicating service and support would be discontinued december 31, 2018.There were no patient/clinical safety issues reported.There are no current trends and no further actions are required.Trends for issues with this product are reviewed at product 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.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: BIO-CONSOLE
• 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: 17246710
• MDR Text Key: 318657762
• Report Number: 2184009-2023-00764
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K941921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R95180
• Device Catalogue Number: R95180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• 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