MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for SAFETRACE V 4.0.3 STV4.0.3 manufactured by Haemonetics Corporation Software Solutions.
[80264101]
Haemonetics discovered internally that there was a defect in the zika special labeling modification code which can allow for zika- or cmv- untested units comprising a pool to be labeled as zika negative or zika and cmv-negative on the pooled component. Although this was discovered internally, there are eight users currently utilizing this software customization and five in the software validation phase. This defect affects only those safetrace sites who have installed the zika special labeling modification and who perform testing subsequent to the pooling modification process. A new product technical bulletin will be produced to notify customers that have the customization of this issue. The defect will be fixed as a custom modification.
Patient Sequence No: 1, Text Type: N, H10
[80264102]
The haemonetics software development team discovered an issue on (b)(6) 2017 with a software customization for safetrace that allows customers to have zika special testing labeling. The issue identified that a pooled component may get the zika and/or cmv negative special label when not all components in the pool were tested. If zika test results are committed after the pool occurred for one of the units comprising the pooled component, the pooled component may erroneously get the zika negative special label when not all of the components comprising the pool have been zika tested; similarly a pooled component may get the cmv neg component special label even though not all the units comprising the pool have negative cmv test results. There are currently eight customers that are live with this customization. There are no known products that were released with this label issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2017-00002 |
| MDR Report Key | 6710833 |
| Date Received | 2017-07-13 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-07-13 |
| 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 | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFETRACE V 4.0.3 |
| Generic Name | SAFETRCE |
| Product Code | MMH |
| Date Received | 2017-07-13 |
| Model Number | STV4.0.3 |
| Operator | PHLEBOTOMIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-07-13 |