MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for PCS?2 PLASMA COLLECTION SYSTEM 06002-110-NA manufactured by Haemonetics Corporation.
[185673958]
Donor reported to be diagnosed with a blood clot and high cholesterol. An on-site technician evaluated the pcs? 2 device in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair. There was no evidence of a device malfunction found.
Patient Sequence No: 1, Text Type: N, H10
[185673959]
On (b)(6) 2019 haemonetics was notified of an adverse reaction which had occurred following the plasma donation procedure, utilizing the pcs? 2 plasma collection system. The plasma collection procedure was completed successfully, with no error messages or alarms encountered. The pcs? 2 plasma collection system collected the target volume of 880ml of plasma and 500ml of saline administered per the routine procedure. Upon disconnecting the donor from the pcs? 2 plasma collection system the donor experienced a possible stroke and was transferred to a hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2019-00027 |
| MDR Report Key | 9896336 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-06-19 |
| Date Mfgr Received | 2019-06-19 |
| Device Manufacturer Date | 2008-05-01 |
| 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 | PCS?2 PLASMA COLLECTION SYSTEM |
| Generic Name | PCS2,LIST NO. 06002-110-NA |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 06002-110-NA |
| 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. Hospitalization; 2. Life Threatening | 2020-03-30 |