MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for PCS?2 PLASMA COLLECTION SYSTEM 06002-110-NA-EW manufactured by Haemonetics Corporation.
[183917635]
The donor facility was informed that the donor fell offsite on an unknown date and was taken off life support on (b)(6) 2019. A field service engineer was dispatched and inspected the pcs2 machine and no issues were found. Diagnostics checks were normal and the unit meets manufacturer specifications.
Patient Sequence No: 1, Text Type: N, H10
[183917636]
On (b)(6) 2020, the customer informed haemonetics of a patient fatality following a successful plasmapheresis procedure on a pcs2 plasma collection system. The donor left in good health following the completion of the donation procedure. No medical interventions were necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00019 |
| MDR Report Key | 9848310 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-21 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2011-03-26 |
| Date Added to Maude | 2020-03-18 |
| 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 | PCS?2 PLASMA COLLECTION SYSTEM |
| Generic Name | PCS2,LIST NO,LN06002-110-NA-EW |
| Product Code | GKT |
| Date Received | 2020-03-18 |
| Model Number | 06002-110-NA-EW |
| 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 | 2020-03-18 |