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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELLSKIY CORPORATION HCLL TRANSFUSION 2015 SP1

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WELLSKIY CORPORATION HCLL TRANSFUSION 2015 SP1 Back to Search Results
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.

 
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Brand NameHCLL TRANSFUSION 2015 SP1
Type of DeviceHCLL 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 Key11701710
MDR Text Key247226371
Report Number3006129391-2019-00001
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK160066
Number of Events Reported1
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 Received04/21/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/02/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/21/2021 Patient Sequence Number: 1
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