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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIWARE INFORMATION SYSTEMS, INC. HCLL TRANSFUSION 2016 SP1

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MEDIWARE INFORMATION SYSTEMS, INC. HCLL TRANSFUSION 2016 SP1 Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Application Program Problem (2880); Patient Data Problem (3197)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2018
Event Type  Malfunction  
Event Description

The hcll 2016 sp1 application allows the user to create a crossmatch worksheet that can be re-sorted, for example, numeric by blood product unit number. It has been reported that while the worksheet appears to re-sort the test bars, the application does not honor the sort order change. Subsequently, when the user results observation(s) and interpretation(s) for the units on the worksheet, the results are actually applied to the units in the order prior to the re-sorting. As a result, there is a potential that the crossmatch of a blood product may have test results documented that are the results of a different blood product. This presents the risk of a blood product that was tested and documented as "compatible" may actually be "incompatible".

 
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Brand NameHCLL TRANSFUSION 2016 SP1
Type of DeviceHCLL TRANSFUSION 2016 SP1
Manufacturer (Section D)
MEDIWARE INFORMATION SYSTEMS, INC.
11711 west 79th street
lenexa KS 66214
Manufacturer (Section G)
MEDIWARE INFORMATION SYSTEMS, INC.
11711 west 79th street
lenexa KS 66124
Manufacturer Contact
jon moeckel
11711 west 79th street
lenexa, KS 66214
9133071051
MDR Report Key11701712
MDR Text Key247226132
Report Number3006129391-2018-00001
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 06/06/2018
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 NO INFORMATION
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 Received05/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2017
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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