MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM BLOOD BANK TRANSFUSION; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problems Application Program Problem (2880); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  Other  

Event Description

On (b)(6) 2023, a problem was reported to (b)(6) that a previous complaint regarding how entering donor directed blood products into inventory was giving an option to choose a donation type of directed donor and autologous was a risk and it should always default to directed donor.While performing the current upgrade validations we noticed that the problem was not corrected.This is an excerpt from communication between our it(information technology) and (b)(6), it was such a pleasure meeting with you all this afternoon.I have taken some time to document the different scenarios we tested.Please review the following and make any corrections necessary.I am also attaching a spreadsheet with test cases and observations.Lots of copy paste so it may need some edits on my part.Please review the following summary from our meeting and testing: when directed product barcode is scanned with both allogeneic and directed products built in system, pop-up message is being displayed for user to select the product rather than the directed product being defaulted.In another scenario, with the exact same product type scanned as above, there is no pop displayed if the aborh type embedded with directed use only barcode is scanned.However, the product that defaults is not directed product but the allogeneic product with donation type of directed crossover.Wrong product name with no indication of the mismatch donation type embedded for aborh field (directed use only) and product type field (directed crossover).When only allogeneic product is built and the directed product is scanned, the allogeneic product is defaulted with donation type of "directed crossover" rather than the pop-up "product is not found; product is not aliased" as is expected.Please let me know if this accurately represents the issue and i will forward our investigation to the correct team.Thank you so much for your patience! summary: regulatory compliance issue (b)(4), sr1-(b)(4) description: we downloaded (b)(4) to fix a compliance issue that came in with code level 2018.11 code.We submitted an obligation with the regulatory requirements.This package did not address that issue.I am resubmitting the documentation to be taken back for an obligation for a fix.I am attaching screenshots where previous code worked as designed and was in alignment with regulatory requirements and screenshots after the package in m1805.

• Brand Name: CERNER MILLENNIUM BLOOD BANK TRANSFUSION
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): CERNER CORPORATION
• MDR Report Key: 17079749
• MDR Text Key: 316788015
• Report Number: MW5118230
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1