MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-26 for CRYOSTORE * CS500V2 manufactured by Origen Biomedical.
[21245646]
Origen hardness bag set is used to process cells for stem cell processing. The clamp failure caused the loss of 10 mls of product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4160684 |
| MDR Report Key | 4160684 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-01-23 |
| Report Date | 2014-09-26 |
| Date Reported to FDA | 2014-09-26 |
| Date Reported to Mfgr | 2014-10-10 |
| Date Added to Maude | 2014-10-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOSTORE |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLO |
| Product Code | KSR |
| Date Received | 2014-09-26 |
| Model Number | * |
| Catalog Number | CS500V2 |
| Lot Number | M10045-6V2 |
| ID Number | * |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIGEN BIOMEDICAL |
| Manufacturer Address | 7000 BURLESON RD. BLDG D AUSTIN TX 78744 US 78744 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-26 |