MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-08-21 for CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET R4R9957 manufactured by Baxter Healthcare.
[931776]
This is a case report from baxter that refers to a cryocyte container. During the thawing step, the bag was found cracked and the product was lost. The graft proceeded and succeeded with other available bags. There were no clinical consequences reported. Additional information received indicates that the type of cells stored in the bag were cord blood stem cells. Fill volume was 151ml and the date of fill was in 2008. The technician was not exposed to the blood product as a result of the break. The break was at the bottom of the bag. Per the freezing, thawing, and storage protocol: a freezing press is not used, a nicool plus freezer is used, and the bags are frozen at a specific controlled rate. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[8107322]
The actual sample was not available for evaluation. However, photographs are available and a visual evaluation will be performed based on those. A follow-up report will be submitted when this evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00758 |
| MDR Report Key | 1137748 |
| Report Source | 01,05 |
| Date Received | 2008-08-21 |
| Date of Report | 2008-08-01 |
| Date of Event | 2008-04-29 |
| Date Mfgr Received | 2008-08-01 |
| Date Added to Maude | 2008-11-10 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, COMPLIANCE MGR. |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-08-21 |
| Catalog Number | R4R9957 |
| Lot Number | H00G10046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1269647 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-21 |