MAUDE Adverse Event Report: PERFUSION SYSTEMS AUTOLOG IQ; APPARATUS, AUTOTRANSFUSION

Model Number ATLGIQ

Device Problem Mechanical Problem (1384)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported not processing blood in the centrifugal bowl, was verified during service.The service technician observed led 11 would not illuminate during the hlt bowl interruption test.After adjusting the gain, there was significant drift occurring.The issue was resolved by replacing both emitter and detector optical cables.Post-repair testing was performed per specifications.Conclusion: reported event was confirmed.Due to the available information and the age of the instrument the most likely cause is normal component wear out.All associated risks are low and no device related patient/clinical safety issues were 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

Medtronic received information that during use this autolog iq instrument did not process the blood in the centrifugal bowl.The good blood in the centrifugal bowl did not process and was then emptied into the waste bag by the instrument.The instrument was changed out with a backup and there was no reported adverse patient effect.Additional information from mdt field service: no blood transfusion was needed.Patients hct was >30 when he left the room there was about 1500 ccs of fluid in the reservoir that was sent into the waste bag.Hard to determine how much blood that was because of anticoagulant, irrigation, etc that is also in the reservoir.

• Brand Name: AUTOLOG IQ
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 17117312
• MDR Text Key: 317050626
• Report Number: 2184009-2023-00501
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00643169982864
• UDI-Public: 00643169982864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATLGIQ
• Device Catalogue Number: ATLGIQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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