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

Model Number ATL2001

Device Problems Device Alarm System (1012); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of an autolog wash kit, the customer reported that the wash kit did not work.There was evidence of blood outflow at the centrifugal bowl and under the cell saver. the wash kit was replaced with another medtronic device.A noise issue was then noticed with the replacement wash kit and it was replaced to complete the procedure.There was no patient impact associated with this event.  medtronic received additional information stating that when the centrifugal bowl broke the disposable device became cracked.The leak occurred at the fluid outlet, below the device.The fill level was asked but it is unknown.The customer stated that about 1600cc of blood was lost in the canister, and a transfusion was required.The replacement wash kit never processed like it was stuck, the customer stated that there was a noise similar to one where the hood becomes blocked.The customer stated that a center speed error was observed.

Manufacturer Narrative

Additional information: medtronic received additional information that the noise issue was with the replacement medtronic device.The center speed error was not displayed when the replacement wash kit was being used.The customer stated that the center speed error was displayed when the leaking kit was in use.Conclusion: an analysis of this occurrence could not be performed without the returned product.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.Complaints received from july 18 through nov 18,2021 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 in the product pfmeca; therefore, no capa will be initiated at this time.Several attempts were made to obtain additional information, with no or an incomplete response from the user; this investigation will be closed with the information provided.If the product is returned, this complaint file will be reopened, and the analysis will, and investigation will be updated.There were no adverse patient effects as a result of this occurrence.Review of the complaint file indicates sufficient information was provided for completion of this investigation.Medtronic 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.

• 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: 14871846
• MDR Text Key: 295022327
• Report Number: 9612164-2022-02464
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 221338225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Date Device Manufactured: 12/11/2020
• 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 Outcome(s): Required Intervention
• Patient Sex: Female