MAUDE Adverse Event Report: WELLSKIY CORPORATION HCLL TRANSFUSION 2015 SP1

Device Problem Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

The hcll 2015 sp1 application allows users to document the issuance of product to patients.It has been reported that when documenting the issuance of a product, the system is not always appropriately updating the product status from electronic crossmatch (xm) to issued (is) with product fulfillment (pf).As a result, the system could create a documentation error and associated regulatory issue and a possible slowing of care.

• Brand Name: HCLL TRANSFUSION 2015 SP1
• Type of Device: HCLL TRANSFUSION 2015 SP1
• Manufacturer (Section D): WELLSKIY CORPORATION; 11711 west 79th street; lenexa KS 66214
• Manufacturer (Section G): WELLSKY CORPORATION; 11711 west 79th street; lenexa KS 66214
• Manufacturer Contact: jon moeckel ; 11711 west 79th street; lenexa, KS 66214 ; 9133071051
• MDR Report Key: 11701710
• MDR Text Key: 247226371
• Report Number: 3006129391-2019-00001
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other