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

Model Number ATL2001

Device Problem Smoking (1585)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Conclusion: per customer description the reported issue could be categorized according to pfmeca fmea0006-04 rev.Ae in which is ide ntified that the procedure ap4913 rev.B, the possible failures modes list in the section below: a) operation/function: ¿bowl and straw assembly, cover weldment¿, failure mode: ¿bowl out of specifications¿, recurrence:2 , severity:8 , risk zone 1 according to ¿risk assessment and control¿ rev l.B) operation/function: ¿bowl and straw assembly, cover weldment¿, failure mode: ¿weld partiality the cover to the bowl¿, recurrence: 2, severity: 5, risk zone 1 according to ¿risk assessment and control¿ rev l.C) operation/function: ¿place dynamic seal in the centrifuge cover ¿, failure mode: ¿centrifuge cover out of specifications¿ recurrence: 2, severity: 8, risk zone 1 according to ¿risk assessment and control¿ rev l.Reported failure mode could¿ve been caused by ¿bowl out of specifications¿, ¿centrifuge cover out of specifications¿ and/or ¿ weld partiality the cover to the bowl¿.However, this can¿t be attributed of that possible failure mode due to a product analysis is pending to performed by the design site.Non-conformity is related to autolog line only, material in scope is used only for that product.Currently the process controls a) ¿drawing specifications (230288)¿, raw material inspection plan , functional test wash kit/autolog , in-process inspection autolog, leak test 100% , height test 100%.Severity: 8 occurrence: 2 on the operation ¿bowl and straw assembly, cover weldment¿ allows to identify with a failure mode ¿bowl out of specifications¿, b) ¿leak test 100% ¿, ¿functional test wash kit/autolog ¿, ¿setup revision for the welding at the beginning of the shift ¿, ¿calibration of measuring and test equipment¿.Severity: 5 occurrence: 2 on the operation ¿bowl and straw assembly, cover weldment¿ allows to identify with a failure mode ¿weld partiality the cover to the bowl¿, c) ¿drawing specifications ¿, ¿functional test wash kit/autolog ¿, ¿in-process inspection autolog¿, ¿leak test 100% ¿.Severity: 8 occurrence: 2 on the operation ¿place dynamic seal in the centrifuge cover¿ allows to identify with a failure mode ¿centrifuge cover out of specifications.Based on the investigation results can be concluded that the following root causes lead to the origination of the failure mode ¿bowl out of specifications¿, ¿weld partiality the cover to the bowl¿ and/or ¿centrifuge cover out of specifications¿ could not be confirmed since a product analysis is pending to perform by design site, for that reason manufacturing site could not determinate a possible root cause for the reported failure mode.The process was confirmed running according the procedure (functional testing) rev.Aa.Manufacturing site could not confirm that the failure of leak was caused in the manufacturing process.Actions for the manufacturing site will not be established since there is no evidence that the reported complaint was originated by the manufacturing at medtronic.Medtronic will continue monitoring this failure mode for potential trends per trend analysis procedure.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.

Event Description

Medtronic received information that during use, the customer reported full autolog iq consumables were set up with no issues noted.The bowl ran twice to process blood.On the third processing cycle, a loud screeching noise occurred and a burning smell was noted.The cycle was stopped and the collected was aborted.At the time, approx.250ml of rbc was collected which was discarded.The device was not replaced to complete the case, collection was abandoned.There was no adverse effect to the patient.Additional information from the sales rep: the bowl or tubing was not re-seated/reinstalled/replaced.The noise came from the centrifuge during the processing of the third bowl.No damaged was noted to the instrument.Unknown about the disposable.No error messages came up so the device seemed to be working as normal.The stop button pressed when the noise started.

• 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: 17238628
• MDR Text Key: 319028067
• Report Number: 9612164-2023-02921
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 220694860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2020
• 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 Sex: Female