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 MCS?+ MOBILE COLLECTION SYSTEM 09000-220-ED manufactured by Haemonetics Corporation.
[185672265]
Limited donor/patient information was provided at this time. Follow up with donor indicated there were no lasting signs or symptoms resulted from reaction. The customers onsite technician was scheduled to evaluate the device.
Patient Sequence No: 1, Text Type: N, H10
[185672266]
On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during the plasma donation procedure, utilizing the mcs? + mobile collection system. The plasma collection procedure was discontinued, donor experienced vomiting and a vasovagal faint episode. There were no error messages or alarms experienced during the procedure. The amount of plasma collected by the mcs? + mobile collection system was unknown, however 500ml of saline was administered. Following the administration of saline compensation, the donor made a full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2018-00054 |
| MDR Report Key | 9896331 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 1999-07-01 |
| 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 |
| 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 | MCS?+ MOBILE COLLECTION SYSTEM |
| Generic Name | LIST NO: 09000-220-ED,MCS+ |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 09000-220-ED |
| 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. Other | 2020-03-30 |