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

Model Number ATLG110

Device Problem Mechanical Problem (1384)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported wash cycle issue was verified during service.Service technician observed reported issue.The issue was resolved by replacing the cobra kit, detector, overlay display, bulb lamp.Preventive maintenance was performed as per specification.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, it was reported that the unit was switching over to wash cycle very quickly, and was giving a very watered down product.Customer cleaned off sensors and this did not change nothing.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was no damage noted in the instrument or the disposable.Re-seated reinstalled tubing, no damage to the tubing was observed.The watered down product was sent to holding bag, customer tried to reprocess again several times but still didn¿t process properly.The product was eventually discarded.

Manufacturer Narrative

Device evaluation summary: the reported wash cycle issue was verified during service.Service technician observed reported issue.The issue was resolved by replacing the cobra kit, detector, overlay display, bulb lamp.Preventive maintenance was performed as per specification.Correction d9: instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center 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.

Manufacturer Narrative

Correction h6: updated the fdc and fdr codes 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 INSTRUMENT
• 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: 19069527
• MDR Text Key: 339679574
• Report Number: 2184009-2024-00161
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093535
• 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,Followup
• Report Date: 05/02/2024

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: ATLG110
• Device Catalogue Number: ATLG110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 03/14/2024; Not provided
• Supplement Dates FDA Received: 04/09/2024; 05/02/2024
• 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