MAUDE Adverse Event Report: PERFUSION SYSTEMS AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number ATL2001

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Conclusion: during analysis no leaks or damage to any of the components were observed.Performance testing indicated that the device functioned as intended.Medtronic visually examines and leak tests 100% of autolog wash kits prior to release for distribution.In addition, a full functional test is performed on a sample unit from each manufactured lot using an autolog instrument.Based on our assessment, we do not have evidence at this time that the reported event was the result of a manufacturing error.We will continue to monitor for similar events.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 the autolog centrifuge bowl leaked.It was asked but unknown how much blood was lost as a result of the leak.The customer stated the transfusion was required as a result of the leak.The product was replaced.The patient received a packed cell of blood.There was no adverse effect to the patient.

• Brand Name: AUTOLOG WASH KIT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9915222
• MDR Text Key: 187372313
• Report Number: 9612164-2020-01453
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 218415404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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 Age: 68 YR
• Patient Weight: 82