MAUDE Adverse Event Report: CERNER CORPORATION BLOOD BANK TRANSFUSION; HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION, PRODUCT CODE: MMH

Model Number 2007.19 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2020

Event Type  Death  

Manufacturer Narrative

Cerner distributed a flash notification february 5, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.

Event Description

This report documents information related to an issue identified with functionality included in cerner's hna(r) millennium pathnet(r) blood bank transfusion (class ii, product code = mmh).This issue involves cerner's millennium users that utilize the combine function (hna combine.Exe) to complete an encounter move for one patient with multiple abo/rh results to a combined patient with the same abo/rh results.When this issue occurs, the abo/rh is removed from the combined patient.If a patient does not have an abo/rh recorded in the system, the system does not allow users to complete a crossmatch or dispense a blood product for that patient.This could lead to a delay in dispensing blood products for a patient if blood bank personnel are not aware that the abo/rh has been removed.A new abo/rh result would need to be entered on the combined patient before they can dispense blood products via the system to the patient.Cerner has received communication on an adverse patient event as a result of this issue.A patient was delayed a blood product transfusion because of this issue.The patient did receive blood products and was pronounced deceased later same day but is unknown if the issue was a contributary factor.

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2021 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner distributed a revised flash notification (b)(6) 2021 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification has been released to address the issue for all sites that could be potentially impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.

Event Description

This report documents information related to an issue identified with functionality included in cerner's hna® millennium pathnet® blood bank transfusion (class ii, product code = mmh).This issue involves cerner's millennium users that utilize the combine function (hna combine.Exe) to complete an encounter move for one patient with multiple abo/rh results to a combined patient with the same abo/rh results.When this issue occurs, the abo/rh is removed from the combined patient.If a patient does not have an abo/rh recorded in the system, the system does not allow users to complete a crossmatch or dispense a blood product for that patient.This could lead to a delay in dispensing blood products for a patient if blood bank personnel are not aware that the abo/rh has been removed.A new abo/rh result would need to be entered on the combined patient before they can dispense blood products via the system to the patient.Cerner has received communication on an adverse patient event as a result of this issue.A patient was delayed a blood product transfusion because of this issue.The patient did receive blood products and was pronounced deceased later same day but is unknown if the issue was a contributary factor.

• Brand Name: BLOOD BANK TRANSFUSION
• Type of Device: HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION, PRODUCT CODE: MMH
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 11288175
• MDR Text Key: 230579005
• Report Number: 1931259-2021-00003
• Device Sequence Number: 1
• Product Code: MMH
• UDI-Device Identifier: 00853023006173
• UDI-Public: 00853023006173
• Combination Product (y/n): Y
• PMA/PMN Number: BK990007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2007.19 - 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death