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

Model Number ATL2001

Device Problem Crack (1135)

Patient Problem Blood Loss (2597)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for assessment as it was discarded by the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the first cycle (filling process) of an autolog washkit, the customer noted a ¿speed error¿ on the autolog instrument and they reset the instrument.When restarted, the same issue occurred and the washkit was broken.They stopped the machine, clamped the pipe between the reservoir and washkit and the suction system for reservoir still worked.They removed the washkit, checked the error, cleaned (removed blood with antiseptic agent), checked the machine that it could work properly and changed the washkit.They had to waste the blood in the bowl, about 70-80 ml.The blood could not be returned to the patient.Information received on january 12th, 2020 stated that the patient needed a blood transfusion of around 2 units or 400 ml as a result of the reported malfunction.The patient received the transfusion at the end of the surgery.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion; no root causes were confirmed as a result of this investigation.The affected product could not be analyzed at design site.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9606809
• MDR Text Key: 182397783
• Report Number: 9612164-2020-00332
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 217254960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2019
• 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