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U.S. Department of Health and Human Services

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

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HAEMONETICS CORPORATION SOFTWARE SOLUTIONS NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0 Back to Search Results
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.

 
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Brand NameNEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0
Type of DeviceNEXTGEN 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 Key7137373
MDR Text Key95818787
Report Number2951268-2017-00004
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK150330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberNEXTGEN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/27/2017
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 Unkown

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