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

Model Number ATLGIQ

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 04/05/2024

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autologiq instrument, it was reported that blood was sent to the waste bag and the unit was leaking out from the bottom.The instrument was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that neither an error nor warning message was displayed.The patient did not require a transfusion of non-autologous blood.The blood sent to the waste bag was discarded.The customer could not provide the amount of blood that was sent to the waste bag.

Manufacturer Narrative

Device evaluation summary: the reported issue that blood was sent to the waste bag and the unit was leaking out from the bottom was verified during service.The issue was resolved by cleaning the optics, removing the top assembly and centrifuge and re-routing the optic cables away from the centrifuge.Preventive maintenance was performed per specifications.Note: the instrument was serviced 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.

• 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: 19212596
• MDR Text Key: 341642953
• Report Number: 2184009-2024-00267
• 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: 04/30/2024

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: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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