MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number ATL2001

Device Problem Obstruction of Flow (2423)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

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 a autolog wash kit, it was reported that the patient went to the department of orthopedics and underwent lumbar intervertebral disc bone marrow nucleus removal and internal fixation under general anesthesia.The customer stated that it was assessed that the surgery would take a long time and cause excessive bleeding, so autologous blood recovery was planned.When the blood filtration was completed and the blood was ready for transfusion, it was found that there was a lot of floc in the filtered blood.After joint confirmation by the director of the anesthesiology department, the surgeon, the anesthetist, and the circulating nurse, it was decided not to give the patient an infusion, which would cause the patient to lose a large amount of his own blood and may cause harm to the patient.The patient was under anesthesia, and the operating room urgently obtained blood transfusion from the blood bank, and the surgery was completed successfully.The customer stated that after a subsequent on-site inspection by the manufacturer, no specific reason was found, and it was only stated that the consumables of the autologous blood return transfusion system would be adjusted and improved.The use of the device was unspecified.There was no reported adverse patient effect associated with this event.

Manufacturer Narrative

Medtronic received additional information that the floc was initially determined to be components in the blood.The blood has been discarded and has not been reinfused to the patient.The amount of discarded blood was approximately 180ml.The engineer came to check that the equipment was normal and provided operational training.The problem has now been resolved.After replacing the consumables, the surgery could be completed normally.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 WASH KIT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19069189
• MDR Text Key: 339667337
• Report Number: 9612164-2024-01665
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 226734344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/02/2024
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male