MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for PCS?2 PLASMA COLLECTION SYSTEM 06002-CP-110 manufactured by Haemonetics Corporation.
[185269701]
The machine was taken out of service once the customer was informed of the death, however the machine was used after the event and functioned normally. Information received from donors brother informed the facility that the death was due to a heart attack. Due to the timing of the incident and the time of death, the machine was not inspected.
Patient Sequence No: 1, Text Type: N, H10
[185269702]
On (b)(6) 2020, haemonetics was informed by the customer of a donor death following a successful plasma donation on a pcs2 plasma collection system. The donor left in good health following the completion of the donation procedure. No medical interventions were necessary. The donor died 10 days after the donation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00025 |
| MDR Report Key | 9889936 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 1997-12-22 |
| Date Added to Maude | 2020-03-27 |
| 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. 06002-CP-110 |
| Product Code | GKT |
| Date Received | 2020-03-27 |
| Model Number | 06002-CP-110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2020-03-27 |