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-EXP-EW manufactured by Haemonetics Corporation.
[185472502]
There was no adverse reaction or injury experienced during the donation procedure. 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
[185472503]
On (b)(6) 2019 haemonetics was notified of a donor fatality which had occurred within 48 hours of the donor's last plasma donation procedure, utilizing the pcs? 2 plasma collection system. The plasma collection procedure was discontinued due to low flow. The pcs? 2 plasma collection system collected 723ml of plasma and 500ml of saline administered per the routine procedure. A copy of the donors' death certificate was provided, however the cause of death was unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2019-00061 |
| MDR Report Key | 9896333 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2019-10-07 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2019-10-07 |
| Device Manufacturer Date | 2013-12-01 |
| 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-EXP-EW |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| 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 | 2020-03-30 |