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

Model Number ATL2001

Device Problems Crack (1135); Fluid/Blood Leak (1250); Obstruction of Flow (2423)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of an autolog iq instrument and autolog wash kit, it was reported when the patient was undergoing a cardiovascular operating room (cvor) case, blood escaped from the wash kit and sprayed on to several surgical technicians in the operating room.The wash kit failed at the connector just below the bag.The customer reported that the failure was at the threaded connector, and it was cracked and the consumable tubing most likely was getting coagulated/clogged.The top portion and lower tubing were clamped to stop the leak.All technicians were wearing personal protective equipment (ppe), but one technician had blood in their eyes, one had blood on their face and eyes, and one had blood on their arm.The patient tested negative for blood-borne pathogens.The instrument was not used to complete the case.The instrument was removed from room.The instrument and wash kit were replaced to complete the procedure.The patient died but the death was believed to be a non-equipment related death as per the customer.The customer stated that the failure of the autolog wash kit did not contribute to the patient¿s death.The customer stated that the cause of death is unknown.Medtronic received additional information that there was no noted or mentioned damage to the autolog iq instrument.There were no visual, audible, or performance abnormalities with the instrument.No error warning messages appeared.The leakage occurred near the wash kit waste bag.There was no visible damage to the disposable wash kit prior to use.The customer stated that the wash kit had functioned fine while processing and returning almost 2 liters during the procedure before the issue occurred.The user reported that the empty line disconnected from the holding bag.The spike remained in the bag while the line blew off.

Manufacturer Narrative

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: 15444951
• MDR Text Key: 306161244
• Report Number: 9612164-2022-03453
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 224415330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Date Device Manufactured: 05/30/2022
• 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