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

Model Number ATLGIQ1

Device Problem Mechanical Problem (1384)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autolog iq instrument, it was reported that as was normal practice the autolog iq was set up for routine cardiopulmonary bypass (cpb).No issues were noted with set up of the instrument (precheck pass) or wash kit.Before coming off cpb the customer's practice is to wash and have ready red blood cells (rbc) for patient support on weaning.The customer proceeded to fill and then observed the red blood cell mass being spilled into the waste bag.The instrument was stopped and the bowl blood sent back to the reservoir.It was estimated that 200ml was lost to the waste bag.An older autolog instrument atlg was exchanged for the autolog iq and proceeded to fill, wash, process without incident. there was no patient impact associated with this event.Medtronic received additional information that no damage was noted by the clinician, but service and repair inspection noted that the sensor had a blood film and they cleaned the sensor.There was no visual, audible, or performance abnormalities noted by the clinician.There was no spill or leak from the bowl to the waste bag.The bowl was re-seated and there was no change with the issue.The customer stated that they are unsure about the fill level, but all were adequate in discussion with the clinician at the time of incident.No error message was observed, the instrument failed to sense that the bowl had filled and kept filling pushing what the clinician was certain was viable red call mass to the waste bag.The customer stated that it is unclear if a transfusion was required as part of this issue.When the problem occurred the clinician changed the instrument to an older autolog instrument to process the rest of the recovered blood in reservoir and pump.Medtronic received additional information that the blood that was sent to the waste bag was discarded as the customer considered it to be unsafe to reinfuse into the reservoir and reprocessed.The customer advised that this action did not affect the patient outcome.

Manufacturer Narrative

Device evaluation: the reported issue of red blood cells being sent to the waste bag was not verified during service.The service technician was unable to confirm the fault.The service technician performed and completed the high level test and the instrument passed.The service technician observed lagging with the sensor leds when interrupting the optical path.Upon further investigation the sensor was observed to be dirty and stained with blood.The service technician stated that the lagging was still observed when the sensor was cleaned.The lagging issue was resolved by replacing the assy optics level sensor emitter, assy optics level sensor detector and cable assembly level sensor.The instrument was then left on over the weekend.Upon reinspection, sensor led10/led11 behavior appeared to be normal and the sensor continued to function normally.Post-repair testing was performed per specifications.Conclusion: the reported event was confirmed.The instructions for use (ifu) provides instructions for cleaning and general maintenance.Due to use conditions components can wear or require periodic cleaning.All associated risks are low and no device related patient/clinical safety issues were reported.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.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: 15959226
• MDR Text Key: 308348247
• Report Number: 2184009-2022-00409
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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