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?+ 9000 MOBILE PLATELET COLLECTION SYSTEM 09000-110-E manufactured by Haemonetics Corporation.
[185673098]
Limited donor/patient information was provided at this time. The customers contracted technician was scheduled to evaluate the device and perform any necessary repairs.
Patient Sequence No: 1, Text Type: N, H10
[185673099]
On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during a plasma donation procedure, utilizing the mcs? + mobile collection system. The plasma collection procedure was discontinued, donor experienced symptoms of a hypocalcemic episode. The amount of plasma collected by the mcs? + mobile collection system was unknown. The donor made a full recovery after procedure stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2018-00058 |
| MDR Report Key | 9896327 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2007-11-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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?+ 9000 MOBILE PLATELET COLLECTION SYSTEM |
| Generic Name | MCS?+ 9000 MOBILE PLATELET COLLECTION SYSTEM |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 09000-110-E |
| 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 |