MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-03-26 for NEXTGEN PLASMA MANAGEMENT SYSTEM NEXTGEN 4.0.0P2 - 4.1.0 manufactured by Haemonetics Corporation Software Solutions.
[103682768]
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.
Patient Sequence No: 1, Text Type: N, H10
[103682769]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2018-00003 |
| MDR Report Key | 7370881 |
| Report Source | OTHER |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-26 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXTGEN PLASMA MANAGEMENT SYSTEM |
| Generic Name | D ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2018-03-26 |
| Model Number | NEXTGEN 4.0.0P2 - 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 | 2018-03-26 |