MAUDE Adverse Event Report: WELLSKY CORPORATION. - HEADQUARTERS WELLSKY TRANSFUSION; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number WELLSKY TRANSFUSION

Device Problems Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

Blood bank transfusion software should have stopped us from being able to issue a unit that was still considered frozen in the software.The manufacturer was notified and they realized that a flaw in the software when using the ec workflow allowed the product to be issued.Fda safety report id #: (b)(4).

• Brand Name: WELLSKY TRANSFUSION
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): WELLSKY CORPORATION. - HEADQUARTERS; KS
• MDR Report Key: 11250908
• MDR Text Key: 229656332
• Report Number: MW5099084
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WELLSKY TRANSFUSION
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1