MAUDE Adverse Event Report: CSL PLASMA, INC. ANTI-D DONOR MANAGEMENT AND INVENTORY SYSTEM (ADIMS); BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number V.01

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

Event Type  malfunction  

Event Description

The requirement to have one-year post collection negative test results was included in the user requirement specifications; but was not programmed as intended in the application.The requirement to mark any aliquot with positive test results for destruction is programmed as intended.To this date, there have been no positive aliquots that require destruction.A total of 54 aliquots were impacted.All aliquots had acceptable test results at time of collection.One (1) year post donation test results were not available at time of deglycerolization.Eight (8) aliquots were administered without testing at the time of administration; but received acceptable test results afterwards; 46 aliquots from 7 different donors were administered with no 1 year post donation testing received to date, but had acceptable results at the time of collection.Fda safety report id# (b)(4).

• Brand Name: ANTI-D DONOR MANAGEMENT AND INVENTORY SYSTEM (ADIMS)
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): CSL PLASMA, INC.; boca raton FL 33487
• MDR Report Key: 13416908
• MDR Text Key: 285005432
• Report Number: MW5107093
• Device Sequence Number: 1
• Product Code: MMH
• UDI-Device Identifier: 00860007397615
• UDI-Public: 00860007397615
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR