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

Model Number ATL2001

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The perfusionist stated that this is not the first time clots have been noticed in the holding bag during a dissection case.The perfusionist thinks this has occurred during a dissection case 5 times previous to this event.None of the prior events were reported and the collected blood was discarded and not given to the patient.The details of the additional 5 occurrences were requested, but not available.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of the autolog wash kit at the end of a dissection case clots were observed in the holding bag.Blood collection on the autolog iq instrument was started at 10am till 4pm on the day of the procedure.At the end of the case, clots were noted in the holding bag and the red cell were discarded. approximately 400 ml of blood was discarded as a result of this issue.The patient required a blood transfusion as a result of the discarded blood.In total 900 ml anticoagulant (heparin in saline) was used for a total of 3.6l collected in the reservoir (unknown amount of irrigation fluid).During the case, bio-glue and fibrillar and surgicel were used but they were not used when the cell saver sucker was used to aspirate fluid.Tachosil was used half way through the case and the customer stated that maybe the cell saver sucker was used at the same time.Vitamin k was given pre-bypass and post-bypass prothrombinex, fibrogen concentrate and platelets were given at the head end.Protamine was given at 3.50pm.The collected red cells were looked at in the holding bag at the end of the case.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12576211
• MDR Text Key: 274727631
• Report Number: 9612164-2021-03823
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 221193601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Date Device Manufactured: 11/24/2020
• 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