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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

The software had been configured incorrectly by the user.To correct the problem, the item is inactivated in the software.It is found that this inactivation does not always take place even though it is documented as inactivated.This situation allowed the issue of a mislabeled blood product.To correctly inactivate the necessary setting, the manufacturer has to do it.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; overland park KS 66210
• MDR Report Key: 10770372
• MDR Text Key: 214391354
• Report Number: MW5097595
• Device Sequence Number: 1
• Product Code: MMH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR