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-CP-220 manufactured by Haemonetics Corporation.
[185672381]
The findings at the hospital were unknown. There were no samples provided and a field service engineer did not evaluate the suspected device. The machine was continued to be used without issues and further procedures were performed after the incident.
Patient Sequence No: 1, Text Type: N, H10
[185672382]
On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during the plasma donation procedure, utilizing the pcs? 2 plasma collection system. The plasma collection procedure was not completed, the pcs? 2 plasma collection system collected 486ml of plasma. The donor experienced a hypertensive crisis and was transferred to a hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2018-00027 |
| MDR Report Key | 9896325 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-07-23 |
| Device Manufacturer Date | 2000-10-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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-CP-220 |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 06002-CP-220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2020-03-30 |