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

Model Number ATLGIQ1

Device Problem Mechanical Problem (1384)

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: the reported issue that the instrument would not stop when sufficient red blood cells were reached was not verified during service.The service technician did not find any problems with the instrument, related to the reported issue.The error logs were downloaded and error 17 (abrupt power down) was seen in the log, this error indicates that the system was unplugged from the wall while it was running.The service technician powered up the instrument and the power on self-test (post) was successfully completed.The instrument passed all functional tests.Preventive maintenance was performed per specifications.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 iq instrument, it was reported that the instrument would not stop when sufficient red blood cells were reached, it kept pushing whole blood through and lost all the cells to the waste bag.Approximately 1000ml of patient blood was lost.The instrument was replaced to complete the procedure.The patient associated with this event died.Medtronic received additional information from service and repair, that the wash bowl of the autolog wash kit set overfills causing viable rbcs of patient to spill over into waste bag.The instrument continues doing this until all blood collected in reservoir has been wasted.The issue seems to be that the instrument is not detecting when centrifugal bowl is full, so it continues drawing patient blood from the collection reservoir and overfilling.No audible or visual alarms are given during this malfunction.The customer was unable to then provide autologous volume resuscitation to a patient with an active abdominal aortic rupture.Once it was noticed that the instrument was not functioning correctly, it was pulled from use and replaced with a functioning instrument to prevent further loss of patient blood.Homologous packed rbcs were then also ordered from the hospital blood bank to replenish what the patient had lost.Ultimately, the attempted surgical repair of the patient's abdominal aorta was unsuccessful and the patient expired in the operating room.Per the customer, the cause of death was ruptured abdominal aortic aneurysm and approximately 1000ml of patient blood wasted prior to switching to a new instrument.Medtronic received additional information that it is unknown what caused the rupture, and does not specify in the medical chart.The patient came into the emergency department at the (b)(6) hospital complaining of severe abdominal pain.Was diagnosed with a ruptured abdominal aortic aneurysm before being transferred to (b)(6) for emergency surgery.The blood lost in the waste bag was discarded.It violates protocol to return contents of the waste bag back to the collection reservoir.The patient ended up being transfused with 16 units of packed red blood cells from (b)(6) hospital blood bank.

• 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: 18694960
• MDR Text Key: 335248706
• Report Number: 2184009-2024-00078
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATLGIQ1
• Device Catalogue Number: ATLGIQ1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• 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 Outcome(s): Required Intervention