MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS NEXTGEN PLASMA MANAGEMENT SYSTEM; D ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number NEXTGEN 4.0.0P2 - 4.1.0

Device Problems Device Operates Differently Than Expected (2913); Programming Issue (3014)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Haemonetics has identified an issue with the nextgen software, when using the swap-collection or change-collection-donor features of nextgen.These features allow customers to correct their records when staff make mistakes in recording collections.The error occurs if one of the donors involved in the swap or change-collection operation has had an rbc loss.Due to the error, a rbc deferral would not be created for the correct donor.Haemonetics has released a technical bulletin to the haemonetics download center on march 16 2018, which notifies haemonetics field services of the potential software issue which impacts only two customer sites.Additionally, haemonetics is going to release an updated version of the nextgen software which will correct this issue in the software.The patch is planned to be released during the summer of 2018.

Event Description

On (b)(4) 2018, internal testing found an error when using the swap-collection or change-collection-donor features of nextgen.These features allow customers to correct their records when staff make mistakes in recording collections.The error occurs if one of the donors involved in the swap or change-collection operation has had an rbc loss.Due to the error, a rbc deferral would not be created for the correct donor.This issue was reviewed on feb 28, 2018 and determined to be a potential health and safety risk.If a donor has an rbc loss that should result in a deferral, and the collection was involved in a swap or change, the deferral may be applied to the wrong donor.

• Brand Name: NEXTGEN PLASMA MANAGEMENT SYSTEM
• Type of Device: D ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7370881
• MDR Text Key: 103682768
• Report Number: 2951268-2018-00003
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEXTGEN 4.0.0P2 - 4.1.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1