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 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported issue of blood being sent to the waste bag was verified during service.The service technician ran the level over diagnostic and found that the level sense gain was 96% and the current was 40.126 ma.The service technician cleaned the optical emitter and detector to return the level sense gain to 99.8% and adjusted to 100%.Preventive maintenance was performed per specifications.Note: the instrument was serviced/analyzed in the facility by a field service technician.The instrument was not returned to a medtronic facility for service/analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during use of an autolog instrument, the customer reported that the instrument was dumping blood directly into the waste bag.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the waste blood was discarded.The amount of discarded blood was not recorded.There was no transfusion required.

Manufacturer Narrative

Correction h11, device evaluation summary: the technician also found that the led 11 was unresponsive and reseated the emitter and detector cables to resolve the problem.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19110479
• MDR Text Key: 340902869
• Report Number: 2184009-2024-00186
• 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,Followup
• Report Date: 05/17/2024

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: ATLGIQ
• Device Catalogue Number: ATLGIQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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