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U.S. Department of Health and Human Services

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

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CERNER CORPORATION BLOOD BANK TRANSFUSION; HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION, PRODUCT CODE: MMH Back to Search Results
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.
 
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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 Key11288175
MDR Text Key230579005
Report Number1931259-2021-00003
Device Sequence Number1
Product Code MMH
UDI-Device Identifier00853023006173
UDI-Public00853023006173
Combination Product (y/n)Y
PMA/PMN Number
BK990007
Number of Events Reported1
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 Number2007.19 - 2018.01
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/05/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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