MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-20 for TEG? HEMOSTASIS ANALYZER SYSTEM TEG 6S UNIT PACK manufactured by Haemonetics Corporation.
[180167282]
Results were achieved after 4 cartridges were used. Customer indicated to haemonetics that delay in processing was not responsible for patient death. A field service engineer was dispatched and inspected the teg6s and checked the calibration settings of the unit and found no issues. Ran qc levels 1 and 2. Unit meets manufacturer specifications.
Patient Sequence No: 1, Text Type: N, H10
[180167283]
On (b)(6) 2020, customer informed haemonetics of a patient fatality that happened at (b)(6) medical center in (b)(6). Palette mapping, on a teg6s, gave a sudlite error in the middle of testing and there was a delay in obtaining the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00012 |
| MDR Report Key | 9733033 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2020-02-20 |
| 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 SHAUN FLANAGAN |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON, MA |
| Manufacturer Country | US |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEG? HEMOSTASIS ANALYZER SYSTEM |
| Generic Name | TEG 6S US UNIT PACK |
| Product Code | JOZ |
| Date Received | 2020-02-20 |
| Model Number | TEG 6S UNIT PACK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION |
| Manufacturer Address | 125 SUMMER STREET BOSTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-20 |