MAUDE Adverse Event Report: MEDTRONIC MEXICO ONE SOURCE PACK ATLS02; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS02
Medical Device Problem Codes	Device Alarm System (1012); Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that during use of an autolog one source pack, it was reported that the centrifuge bowl failed and blood spilled outside the bowl.Customer could not complete the cell salvage procedure.See attached photos.Use of device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Medtronic received additional information that the customer was unable to identify any cracks because the washer was stained with blood when it was removed from the compartment.The compartment was stained with blood.They observed a pool of blood beneath the machine.There was no visual, audible, or performance abnormalities.The bowl and other consumable were not replaced or re-installed.The fill (fluid) level of the reservoir was 900ml, the holding was 250ml, the saline was 150ml and there was 1750ml of fluid in the waste bag at the time of the issue.An error warning message appeared stating that the centrifuge failed.The error code 12 appeared.The patient lost a total blood amount of 2200ml during the surgery.They performed one round of washing and they collected approximately 150ml of blood but they were unable to transfuse it back to the patient.The blood was not flowing out for the bag.A transfusion was required as a result of this leak.They transfused 1000ml of blood.Additional information h6.Patient codes (ime/annex e), device codes (fdd/annex a):these fields have been updated additional codes: imf (annex f) health impact: this field was updated.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: ONE SOURCE PACK ATLS02
• Common Device Name: 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: 20639231
• Report Number: 9612164-2024-05163
• Device Sequence Number: 7443290
• Product Code: CAC
• UDI-Device Identifier: 00643169108332
• UDI-Public: 00643169108332
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K093535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2025
• Device Model Number: ATLS02
• Device Catalogue Number: ATLS02
• Device Lot Number: 0228557607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG