MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for PCS?2 PLASMA COLLECTION SYSTEM PCS2,LIST NO,06002-110-EXP-EW manufactured by Haemonetics Corporation.
[183335175]
It was noted that the donor has a significant pre-existing medical problem. Four days prior to the donation on (b)(6) 2019 the donor developed tingling in his right arm as well as pain and heaviness in his chest associated with shortness of breath while playing basketball. Donor passed out and fell on the back of his head. Abnormal ekg changes and concern for cardiac origin was noted. This was not communicated to the donor facility. A field service engineer was dispatched and inspected the pcs2 machine and found no issues. The device is operating within manufacturer's specifications.
Patient Sequence No: 1, Text Type: N, H10
[183335177]
On (b)(6) 2019, haemonetics was informed by the customer of a donor fatality following a successful plasmapheresis procedure on a pcs2 plasma collection system. The donor began seizure-like motions on the donor bed prior to the needle being disconnected. Chest compressions were performed by medical staff until ems arrived. Donor died at the hospital later that day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00026 |
| MDR Report Key | 9831412 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2019-12-15 |
| Date of Event | 2019-11-24 |
| Date Mfgr Received | 2019-12-15 |
| Device Manufacturer Date | 2014-05-16 |
| Date Added to Maude | 2020-03-13 |
| 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,06002-110-EXP-EW |
| Product Code | GKT |
| Date Received | 2020-03-13 |
| Model Number | PCS2,LIST NO,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 | 2020-03-13 |