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

Model Number ATLGIQ1

Device Problems Device Alarm System (1012); Optical Problem (3001)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 of an autolog one source pack and an autolog iq instrument, it was reported that when the customer was in the middle of the scheduled aortic arch replacement surgery and aortic valve change, of which the autolog iq instrument and the autolog one source pack were an essential tool for the surgery, the customer observed that during the surgery and while the team was working with the instrument programmed in automatic mode, the instrument began to present faults in the filling process of the hood and the washing process.The customer stated that by monitoring the process of cell recovery, they were able to realize that the waste material was not correlating with the material recovered by the centrifugal bowl.The customer observed the following failures in the equipment and the process of collecting red blood cells, the hood in the filling process was leaking solution into the waste bag, crystalloid with which the system was washed and with which it was aspirated in the surgical field, together with residual blood, which the sensor system did not seem to be able to identify and carry out the separation process of the hematolog ical elements, plasma and residues of crystalloids and evenly discarded all the material.The customer stated that this left bad centrifugal bowl quality and it was unsafe to be transfused to the patient.The customer also observed that when the centrifugal bowl was recovered, the autolog iq instrument showed a recovery of 230 ml red blood cells, later when the customer wanted to retrieve a second centrifugal bowl using the concentrate program, it gave a recovery of 190 ml, a result that made the customer doubt the processes of recovery and washing of the hood and the autolog iq instrument.The customer decided not to use the recovered material since it represented a risk in the transfusion of the blood product as they were not 100% sure that the process was adequate.The autolog iq instrument gave a message on the display of 0 days for maintenance.The customer stated that when removing the centrifugal bowl to see if it had been hit or the consumable had come out defective, it was observed that it had a slight leak of diluted hematic material within where the base of it was placed.The use of the one source pack and instrument was unspecified.There was no adverse patient effect associated with this event.

Manufacturer Narrative

Medtronic received additional information that the leak was coming from the top of the wash kit, where it fits with the autolog instrument.There was no damage to the wash kit or the autolog iq instrument, but a maintenance service error message appeared on screen of the autolog iq.There was no visual, audible, or performance abnormalities noted.The bowl or tubing was not re-seated/reinstalled/replaced.The amount of patient blood loss can not be provided, and no transfusion was required.The blood was discarded.The instrument will not be serviced.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.

Manufacturer Narrative

Correction h6 patient codes (ime/annex e): this code has been updated.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.

• 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: 17422887
• MDR Text Key: 320014556
• Report Number: 2184009-2023-00866
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K181954
• 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,Followup,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATLGIQ1
• Device Catalogue Number: ATLGIQ1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Date Device Manufactured: 09/01/2020
• 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
• Patient Sex: Female
• Patient Weight: 75 KG