MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2017-12-21 for NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0 manufactured by Haemonetics Corporation Software Solutions.
[95818787]
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.
Patient Sequence No: 1, Text Type: N, H10
[95818788]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2017-00004 |
| MDR Report Key | 7137373 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID RAMSAY |
| Manufacturer Street | 400 WOOD ROAD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7813487327 |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 400 WOOD ROAD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0 |
| Generic Name | NEXTGEN 3.1.0 P1, 4.0.0 P2, 4.1.0 |
| Product Code | MMH |
| Date Received | 2017-12-21 |
| Model Number | NEXTGEN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
| Manufacturer Address | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 EL DORADO HILLS CA 95762 US 95762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-21 |