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

Device Problems Incorrect, Inadequate or Imprecise Result or 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".

• Brand Name: HCLL TRANSFUSION 2016 SP1
• Type of Device: HCLL 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 Key: 11701712
• MDR Text Key: 247226132
• Report Number: 3006129391-2018-00001
• 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: 06/06/2018

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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