MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for PCS?2 PLASMA COLLECTION SYSTEM 06002-110-NA manufactured by Haemonetics Corporation.
[185472525]
Haemonetics sent a field service engineer to evaluate the pcs? 2 device in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair. There was no evidence of a device malfunction found.
Patient Sequence No: 1, Text Type: N, H10
[185472526]
On (b)(6) 2019 haemonetics was notified of a donor fatality which had occurred within 24 hours of the donor's last plasma donation procedure, utilizing the pcs? 2 plasma collection system. During the plasma collection procedure, the donor reported to have lost consciousness. The donors' vitals were within normal limits, donor returned to homeostasis prior to leaving the center. The pcs? 2 plasma collection system collected 879ml of plasma and 500ml of saline administered per the routine procedure. The cause of death was reported to be not known, a copy of the coroner's report was not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2019-00054 |
| MDR Report Key | 9896334 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2019-09-17 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2020-03-30 |
| 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. JANICE KISER |
| 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. 06002-110-NA |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 06002-110-NA |
| 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 | 2020-03-30 |