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 PCS?2 PLASMA COLLECTION SYSTEM 06002-CP-220 manufactured by Haemonetics Corporation.
[185673318]
The hospital diagnosed the donor with circulatory dysregulation with hyperventilation and tachycardia of unknown origin. Haemonetics sent a field service engineer to evaluate 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
[185673319]
On (b)(6) 2018 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 655ml of plasma and 250ml of saline administered. After the donation, the donor experienced chest pain, difficulty with breathing, paleness and tingling around the mouth. Donor was transferred to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2018-00025 |
| MDR Report Key | 9896329 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-07-04 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 1994-08-01 |
| 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-CP-220 |
| Product Code | GKT |
| Date Received | 2020-03-30 |
| Model Number | 06002-CP-220 |
| 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. Hospitalization | 2020-03-30 |