MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for PCS?2 PLASMA COLLECTION SYSTEM 06002-CP-110 manufactured by Haemonetics Corporation.
[184303511]
Donor was monitored and was stable upon release. A field service engineer was dispatched and inspected the pcs2 machine. The engineer realigned centrifuge lid and tightened loose hardware. The blood pump motor was also replaced. Calibrations checked and adjusted as required. Unit meets manufacturer specifications. Photo analysis of the bowl shows a bowl full of dark colored red blood cells. No evidence of damaged red blood cells are visible. No defects that could possibly create hemolysis were identified (no folds, molding defects, sharp or rough edges, foreign objects).
Patient Sequence No: 1, Text Type: N, H10
[184303512]
On february 21, 2020, haemonetics was informed by the customer of an adverse event and device malfunction during a plasmapheresis procedure. There was a possibility of the donor receiving hemolized red blood cells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00024 |
| MDR Report Key | 9860898 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | 06002-CP-110 |
| 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. Other | 2020-03-20 |