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 CELL SAVER? 5 AUTOLOGOUS RECOVERY SYSTEM 02005-220-E manufactured by Haemonetics Corporation.
[185672256]
Limited donor/patient information was provided at this time. Haemonetics has not received any additional information regarding donors condition or medical outcome. A haemonetics field service engineer evaluated the suspected device and found that the unit meets all specifications, there were no faults observed.
Patient Sequence No: 1, Text Type: N, H10
[185672257]
On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during a cell savage procedure, utilizing the cell saver? 5 autologous recovery system. The cell savage procedure was discontinued after 4 attempts to reinfuse donor were made. The donor experienced hypotensive reactions which worsened on each infusion attempt, the fourth and final attempt was terminated after only 10ml of salvaged rbcs were infused to the patient. Donor was transferred to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2018-00046 |
| MDR Report Key | 9896328 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2002-01-08 |
| 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 | CELL SAVER? 5 AUTOLOGOUS RECOVERY SYSTEM |
| Generic Name | CS5,220V ENGL,LN 02005-220-E |
| Product Code | CAC |
| Date Received | 2020-03-30 |
| Model Number | 02005-220-E |
| 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 |