MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for PCS?2 PLASMA COLLECTION SYSTEM 06002-110-EXP-EW manufactured by Haemonetics Corporation.
[183853962]
There was no adverse reaction or injury experienced during the donation procedure, the donor was reported to have left the center in good health. A haemonetics field service engineer evaluated the suspected device and found that the unit meets all specifications, there were no faults observed.
Patient Sequence No: 1, Text Type: N, H10
[183853963]
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. The plasma collection procedure was completed successfully. The pcs? 2 plasma collection system collected the target volume of 824ml of plasma and 500ml of saline administered per the routine procedure. The cause of death was reported to be a heart attack; however a copy of the coroner's report was not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2019-00014 |
| MDR Report Key | 9845736 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-03 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2015-07-06 |
| Date Added to Maude | 2020-03-17 |
| 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-EXP-EW |
| Product Code | GKT |
| Date Received | 2020-03-17 |
| Model Number | 06002-110-EXP-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 | 2020-03-17 |