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

Model Number ATLGIQ

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autolog iq, it was reported that the instrument had a noisy centrifuge and is dumping product directly into the waste bag.The instrument was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that there was no damage to the instrument.The disposable was not available for examination.The performance issue was that unprocessed blood product was being directly sent to the waste bag.The device was immediately removed from service and the disposable was discarded.There was no error message.Additional information received indicates blood and waste fluid sent to the waste bag are typically discarded.

Manufacturer Narrative

Analysis of device - the reported noisy centrifuge and dumping issue was not verified during service.Service technician could not duplicate centrifuge noise.Cleaned and adjusted the optics in an effort to eliminate the immediate transfer of fluid to the waste bag, and replaced the centrifuge drive.Preventive maintenance was performed as per specification.Analysis was performed at the facility by service and repair.Device was not physically returned to medtronic.The reported event could not be duplicated, the specific cause of the event cannot be determined; however, the most likely cause is normal component wear.All associated risks are low and no device related patient/clinical safety issues were reported.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: 16396712
• MDR Text Key: 310098310
• Report Number: 2184009-2023-00083
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Date Manufacturer Received: 01/20/2023
• Date Device Manufactured: 12/26/2018
• 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