MAUDE Adverse Event Report: CLINISYS INC SUNQUEST LABORATORY - BLOOD BANK AND BLOOD DONOR

Model Number	10.0 AND ABOVE
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
39 sites have been notified by a client notification and a correction will be available in blood bank versions 10.0.1, 10.1.1 and 11.0.1.There are 0 sites that have already been corrected.No instances of patient harm have been reported as a result of this issue.The root cause of this problem is coding logic.When definitions exceed 497 entries the routine handling the maintenance does not look in the correct database location (^tpo(dv,"pkt")) for the definitions.The routine is expecting a variable that no longer contains the information and it processes the definitions as if they all have been removed.
Event or Problem Description
When new gui blood type compatibilities maintenance definitions are saved to the database, if the number of overall compatible and suitable definitions exceeds 497 lines of data, all definitions are removed.If maintenance is removed, and problem code definitions were defined, patient/unit blood type compatibilities based on problem code definitions will not be generated.This could result in a patient receiving incompatible blood.Maintenance for patient/unit blood type compatibility (bma 10,2) are not affected by this issue.

• Brand Name: SUNQUEST LABORATORY - BLOOD BANK AND BLOOD DONOR
• Common Device Name: BLOOD BANK
• Manufacturer (Section D): CLINISYS INC; 3300 e. sunrise dr.; tucson AZ 85718
• Manufacturer (Section G): CLINISYS INC; 3300 e. sunrise dr.; tucson AZ 85718
• Manufacturer Contact: chris harmston ; 3300 e. sunrise dr.; tucson, AZ 85718 ; 7206603377
• MDR Report Key: 15258905
• Report Number: 2029302-2022-00001
• Device Sequence Number: 12215132
• Product Code: MMH
• UDI-Device Identifier: B236BB10000
• UDI-Public: +B236BB10000/$$710000063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK160005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 10.0 AND ABOVE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown