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

Model Number ATL2001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: 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; therefore, no capa will be initiated at this time.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.This investigation will be closed with the information provided.If the product is returned, this complaint will be reopened and the investigation will be updated.There were no adverse patient effects as a result of this occurrence.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, the customer reported that two autolog wash kits leaked blood into the centrifuge.The customer stated that there was no visible damage to the wash kits and blood seemed to leak from the top of the centrifuge.The customer stated that there was a pump speed error and the instrument has been evaluated and is functioning appropriately.The instrument was replaced, and second wash kit in this instrument failed as well, but no pump speed error occurred.Both disposables had the same lot number.This issue only happened with the affected lot number reported.When the customer switched to a different lot number of the product there was no leak.When the issue occurred the reservoir contained about 1200 mls of blood and the waste bag was empty.The failure occurred when attempting to spin the first bowl.1200 mls of blood was lost as a result of the issue and a transfusion was required.No additional patient impact was reported.

Event Description

Medtronic received information that during use, the customer reported that two autolog washkits leaked blood into the centrifuge.The customer stated that there was no visible damage to the washkits and blood seemed to leak from the top of the centrifuge.The customer stated that there was a pump speed error and the instrument has been evaluated and is functioning appropriately.The instrument was replaced, and second washkit in this instrument failed as well, but no pump speed error occurred.Both disposables had the same lot number.This issue only happened with the affected lot number reported.When the customer switched to a different lot number of the product there was no leak.When the issue occurred the reservoir contained about 1200 mls of blood and the waste bag was empty.The failure occurred when attempting to spin the first bowl.1200 mls of blood was lost as a result of the issue and a transfusion was required.No additional patient impact was reported.

Manufacturer Narrative

Medtronic investigation: visual inspection of the returned device indicated no outward signs of damage or abnormalities.No fin, straw, or dimple plate damage was noted, no signs of holes or cracks were detected.The washkit bowl was run a couple of times using saline.During the runs, there was no bowl lift, leaks or pump speed error messages noted.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 document indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.Complaint is unconfirmed for bowl leak.Product analysis confirms there is no issue with the returned device.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
• MDR Report Key: 11567199
• MDR Text Key: 242159382
• Report Number: 9612164-2021-01143
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00673978521862
• UDI-Public: 00673978521862
• 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
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 220511734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention