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

Model Number ATL2001

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: complaint is unconfirmed for bowl leak.An analysis of this occurrence could not be performed without a returned product.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for the same failure mode showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file indicates that the current risk zone does not exceed the risk zone predicted for the product; therefore, no capa will be initiated at this time.This investigation will be closed with the information provided.If the product is returned, this pe will be reopened and the analysis will and investigation will be updated.Medtronic is aware of this occurrence and will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this autolog washkit, when the device was turned on a leak was identified through a crack in the upper part of the material, contaminating the blood inside the machine.The washkit was replaced to complete the procedure.The customer stated that the washkit leaked at the top next to the lid.The leak occurred at the start of the first cycle.One liter of blood was present in the reservoir when the leak occurred.The rest of the washkit was empty at this point.The customer stated there was no error warning message.The customer stated that all of the blood was discarded as a result of the leak, as they were concerned that the blood could have been contaminated and a blood transfusion was required as a result of the leak.

Event Description

Medtronic received information that during use of this autolog washkit, when the device was turned on a leak was identified through a crack in the upper part of the material, contaminating the blood inside the machine.The washkit was replaced to complete the procedure.The customer stated that the washkit leaked at the top next to the lid.The leak occurred at the start of the first cycle.One liter of blood was present in the reservoir when the leak occurred.The rest of the washkit was empty at this point.The customer stated there was no error warning message.The customer stated that all of the blood was discarded as a result of the leak, as they were concerned that the blood could have been contaminated and a blood transfusion was required as a result of the leak.

Manufacturer Narrative

Medtronic investigation: complaint is unconfirmed for bowl leak.An analysis of this occurrence could not be performed without the returned product.After evaluation, the cause of this complaint could not be determined; additional information is needed.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file indicates that the current risk zone does not exceed the risk zone predicted for the product.Therefore, no capa will be initiated at this time.If the product is returned, the complaint will be reopened and the investigation will be updated.Medtronic is aware of this occurrence and will continue to monitor for future occurrences.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 investigation and conclusion according with the event description, there was a leak at the autolog¿s bowl.Visual analysis of the returned complaint device confirmed a broken straw.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A review of similar complaint received found no trends warranting escalation.Assessment against the medtronic risk management file document indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.Medtronic will continue to monitor for future occurrences and trends.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

Medwatch - form fda 3500a a.Patient information: additional information added to the section.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.

• 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
• MDR Report Key: 11573354
• MDR Text Key: 242400429
• Report Number: 9612164-2021-01162
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 219182899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4