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

Model Number ATLS24

Device Problem Obstruction of Flow (2423)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autolog one source pack, it was reported that there was unexplained erythrocyte (red blood cell) coagulation after the blood had been washed.The use of the device was unspecified. the patient impact is unknown, but further information will be requested.It was also reported that the customer has noted the issue on more than one occasion, after centrifuging large volumes.The customer requested that medtronic send a clinical specialist to discuss the issue.Medtronic received additional information that loss of patient blood resulted in patient anemia due to the amount of blood loss.The first time issue occurred customer contacted local technician that does the maintenance of the units.The technician found no issues withthe unit and said it was user error.In total this issue has happened more than 10 times.In one operation we used both devices and both had the same problem.These occurrences was not reported to medtronic.The issue was the filtered blood coagulates in the blood holding bag, and its not possible to transfuse it to the patient due to clotting.

Manufacturer Narrative

Conclusion: medtronic received information that during use of an autolog one source pack, it was reported that there was unexplained erythrocyte (red blood cell) coagulation after the blood had been washed.The use of the device was unspecified.The patient impact was unknown.Medtronic could not confirm or deny the complaint of red blood cell coagulation as no product has been returned.An analysis of this occurrence could not be performed without the returned product.After evaluation and discussions with medtronic clinical specialist, who is also an expert on anticoagulation management, this complaint could possibly be a use-related issue.As anticoagulation delays clots formation, it does not prevent it from happening, when the patient is bleeding rapidly and the customer is processing large blood volumes, it is easy to get behind on anticoagulation.Key tips to prevent this from happening include: increasing the heparin amount from 30,000 units of heparin per 1000 ml of saline to 40,000 units, priming the reservoir with at least 200 ml of anticoagulant, agitating the collection reservoir prior to processing, and re-priming the reservoir with 200 ml of anticoagulant every time it is emptied.The device history record was not reviewed as this issue is not considered to be manufacturing-related.Assessment against the medtronic risk files indicates that the current risk zone does not exceed the risk zone predicted in the risk files.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.

Manufacturer Narrative

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 ONE SOURCE PACK
• 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: 17343697
• MDR Text Key: 320220946
• Report Number: 9612164-2023-03258
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: LG
• PMA/PMN Number: K093535
• 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,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: No
• 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