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

Model Number ATL2001

Device Problem Material Puncture/Hole (1504)

Patient Problem Hypovolemia (2243)

Event Date 10/09/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autolog wash kit, during third cycle of bowl spinning, a crack occurred on the bowl and the machine stopped.A plastic burning smell was detected.An error message "centrifuge speed" was shown.It was noted that there was no significant impact on patient.However, the patient was not able to reinfuse back own blood and had to use allogenic blood.It was asked but unknown as to how much patient blood could not be reinfused, and how much allogenic blood was required.

Manufacturer Narrative

Conclusion: based on the investigation results can be concluded that the following root causes lead to the origination of the failure mode of centrifuge cover out of specification.There was observed damage to the device.However, during the performance testing no failures was detected and the device functions as intended.During dhr review, it was confirmed that the equipment was under validated parameters.After evaluation the cause of this complaint could not be determined.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Assessment against the medtronic risk management file pfmeca document indicates that the current risk zone does not exceed the risk zone predicted in the product pfmeca.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.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 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: 17181492
• MDR Text Key: 317930841
• Report Number: 9612164-2023-02777
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 219822701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2020
• 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