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 NEXSYS PCS, US PCS-300-US manufactured by Haemonetics Corporation.
[184349574]
Customer has not responded to the incident. However a field service engineer was dispatched and replaced ic dc mc board, replaced power supply input cable. Device needs new right and left donor display lights. Device also needs a new cuff compressor. Field service engineer will install the remaining parts.
Patient Sequence No: 1, Text Type: N, H10
[184349575]
On (b)(6) 2020 haemonetics was informed by the customer of a device malfunction resulting in smoke coming out of the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00023 |
| MDR Report Key | 9862352 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| 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 | NEXSYS PCS, US |
| Generic Name | PCS-300-US |
| Product Code | GKT |
| Date Received | 2020-03-20 |
| Model Number | PCS-300-US |
| 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 | 2020-03-20 |