MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-08-22 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare Corporation - Mountain Home.
[21992543]
(b) (4).
Patient Sequence No: 1, Text Type: N, H10
[22126989]
This is a report received on 05-august-2008 by baxter (b) (4) via the distributor, (b) (4) from a healthcare professional. A leakage (crack at the upper corner) on a cryocyte bag was detected after thawing. The cells were transfused from the over-pouch. The product has been used before in the same setting frequently. Additional info received indicates that the total number of target stem cells transplanted was 2. 8x10e6/kg. The intended patient experienced delayed transfusion, prophylactic antibiotics, and a sterility risk. Per the customer's cryocyte processing protocol: dmso was used as a cryopreservant. Any visible air was removed from the bag and an over-wrap was used as well as a controlled rate freezer. The bag is then stored in vapor phase nitrogen for 30 days. The bag was not removed from the final storage temperature at any time. For transport, the bag was placed in a dry shipper filled with liquid nitrogen. The customer was not aware of any damage or deviation from standard procedure that may have occurred to the bag during filling, freezing, storage, transport, or thawing. In addition, there have been no recent changes in protocol, critical equipments/supplies or personnel. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2008-00763 |
| MDR Report Key | 1137533 |
| Report Source | 01,05 |
| Date Received | 2008-08-22 |
| Date of Report | 2008-08-05 |
| Date of Event | 2008-07-28 |
| Date Mfgr Received | 2008-08-05 |
| Date Added to Maude | 2009-12-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, MANAGER |
| 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 500 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-08-22 |
| Catalog Number | R4R9955 |
| Lot Number | H06B01040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION - MOUNTAIN HOME |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-22 |