MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-05-16 for NEXTGEN/NEXLYNK NEXTGEN 4.1.0 manufactured by Haemonetics Corporation Software Solutions.
[108492281]
Haemonetics identified a potential safety risk through internal testing on the nextgen software version 4. 1. 0. It was identified that the nextlynk user management api did not properly manage usernames containing periods. The system could allow a user of the user-management api to unintentionally give security privileges to a different user than intended. This could give the wrong user system privileges to perform actions for which the user is not trained or authorized by sop. A hazardous situation may arise if unauthorized users gain access to the system and cause it to provide unreliable information which could lead to unsuitable donations or unsuitable product release. There have been no observations of this occurrence happening within the nextgen customer production systems, this issue has only been discovered through internal development testing. Haemonetics will directly address this issue with the next version of nextgen software, version 4. 2. 0 is planned to be released by july 2018.
Patient Sequence No: 1, Text Type: N, H10
[108492282]
Haemonetics discovered through internal testing that the nextlynk user management api did not properly manage usernames containing periods (dots). Haemonetics reviewed the details of this incident on (b)(6) 2018 and determined this to be a possible safety risk. The defect could allow an api user to update the security role(s) for a different user than they intended. This could give the wrong user system privileges to perform actions for which the user is not trained or authorized by sop. Security roles and privileges is a design control for a hazard in the hazard analysis, therefore such a defect is being considered a safety risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2018-00004 |
| MDR Report Key | 7520017 |
| Report Source | OTHER |
| Date Received | 2018-05-16 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-16 |
| 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 SOFTWARE SOLUTIONS |
| Manufacturer Street | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 |
| Manufacturer City | EL DORADO HILLS CA 95762 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95762 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXTGEN/NEXLYNK |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2018-05-16 |
| Model Number | NEXTGEN 4.1.0 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-05-16 |