MAUDE Adverse Event Report: WELLSKY CORPORATION HCLL TRANSFUSION; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number 2015.1.1.7

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

The (b)(4) software is configured to produce an error box when abo incompatible units are crossmatched.The message that should display in the box is 'this product is not allowed for selection with override.' this error box nor did the message display in this instance which allowed the unit of red blood cells to be linked to the patient for issue and transfusion.

• Brand Name: HCLL TRANSFUSION
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): WELLSKY CORPORATION; 11300 switzer road; overland park KS 66210
• MDR Report Key: 10689592
• MDR Text Key: 211684906
• Report Number: 10689592
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2015.1.1.7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 61