MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for CELL SAVER ELITE SYSTEM CSE-P-224 manufactured by Haemonetics Corporation.
[185017945]
First bowl of cell saver product was watery. Spun hct = 7. Product was returned to reservoir and added to second bowl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882634 |
| MDR Report Key | 9882634 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-05 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELL SAVER ELITE SYSTEM |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-11 |
| Catalog Number | CSE-P-224 |
| Lot Number | 1219014 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION |
| Manufacturer Address | 125 SUMMER ST BOSTON MA 02110 US 02110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |