MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0

Model Number NEXTGEN

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

Haemonetics discovered an issue with the nextgen software versions 3.1.0 patch 1, 4.0.0 patch 2 and 4.1.0.The software error may result in a donor experiencing an adverse reaction, with the potential for subsequent repeat reactions.This incident was reviewed by a medical director, they have determined that repeated immunizations with different antigens could result in new, different antibody formation, which would complicate the generation of sera for diagnostic use.However, multiple antibody formation, if the antibodies were directed to rbc, could complicate providing compatible rbc for transfusion in the situation where blood was needed.Another scenario would be if the immunized individual developed a reaction to one antigen and now a second antigen is presented through another immunization program, the individual could develop cross-reactivity and subsequent reactions.These reactions would likely require medical intervention, but are not necessarily life-threatening.This issue will be resolved in the next software revision, nextgen version 4.2.0.

Event Description

On (b)(6) 2017, internal testing found an error when reclassing a donor from one immunization program directly to another immunization program.The error occurs if the donor's new program has enabled immunization schedules and the user chooses not to start or resume an immunization schedule in the new program.Due to the error, any existing immunization shots from the old program are not removed from the activity queue.The issue was reviewed on dec 07, 2017 and determined to be a potential health and safety risk.If a donor is reclassed out of the immunization program after experiencing a reaction nextgen could still allow the donor to continue receiving those immunizations, potentially experiencing additional reactions.There have been no reports of this issue from the applicable customer sites from the field, this was only discovered during internal testing at haemonetics.The causal chain analysis is as follows: a donor in an immunization donor program presents at the center and receives an immunization.The donor experiences an immunization related reaction.The donor is reclassed out of the immunization program into a new immunization program, but no immunization schedule is choosen.The center staff don't notice that the immunization shots from the previous immunization program were not cancelled.The immunization shot is approved by physician.The donor presents at the center for a donation.The staff notice that there is an immunization shot due and performs the immunization.The donor experiences an immunization related reaction.

• Brand Name: NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0
• Type of Device: NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7137373
• MDR Text Key: 95818787
• Report Number: 2951268-2017-00004
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NEXTGEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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