MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-25 for CRYOSTORE FREEZING BAG CRYOSTORE 250 EVA BAGS CS250N manufactured by Origen Biomedical.
[20755424]
Autologous peripheral blood stem cells were frozen in two origen cryostor freezing bags. The cells were frozen with cryoprotectant in controlled rate freeze and placed in a vapor phase liquid nitrogen storage container until day of transplant. Upon removal of patient's autologous stem cell product bags from frozen storage a large crack across the face of one of the bags was observed. Due to the potential risk of contamination it was determined by patient's medical staff that the product should not be infused into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037940 |
| MDR Report Key | 4046857 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-04-18 |
| Date Added to Maude | 2014-09-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOSTORE FREEZING BAG |
| Generic Name | CRYOSTORE FREEZING BAG |
| Product Code | KSR |
| Date Received | 2014-08-25 |
| Model Number | CRYOSTORE 250 EVA BAGS |
| Catalog Number | CS250N |
| Lot Number | M50077-1N |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIGEN BIOMEDICAL |
| Manufacturer Address | AUSTIN TX 78744 US 78744 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-25 |