MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-09-25 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare Corporation - Mountain Home.
[20024441]
This is a case, which was reported to baxter in 2008 by the distributor of this product on behalf of the customer. The customer reported that 2 cryocyte freezing containers, storing hematopoietic stem cells collected through apheresis, were discovered to have multiple cracks emanating from one side of each bag, going half way up the bag. This was discovered after freezing. The volume stored in the bags was 97 ml. Per the customer's freezing, thawing, and storage protocol. After the cracks were discovered, the contents of one bag were thawed in a clean room. The cells were then transferred to another bag (baxter 600 ml transfer bag). The contents of the other bag were stored as backup. Sterility testing was completed and the results showed gram-positive cocci. It is unknown at this time if antibiotics were given to the patient due to this incident. Furthermore, engraftment results are pending. The customer is not aware of any damage or deviation from standard procedure that may have occurred to the bag during filling, freezing, storage, transport, or thawing. The customer indicated that neither bag was dropped, but both bags seemed to have suffered thermal shock. In addition, the customer reported that there been no recent changes in protocols, critical equipment/supplies or personnel.
Patient Sequence No: 1, Text Type: D, B5
[20097331]
A follow-up report will be submitted with any additional information received and evaluation results when this is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00826 |
| MDR Report Key | 1185243 |
| Report Source | 01,05 |
| Date Received | 2008-09-25 |
| Date of Report | 2008-09-02 |
| Date of Event | 2008-09-02 |
| Date Mfgr Received | 2008-09-09 |
| Device Manufacturer Date | 2006-09-08 |
| 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, 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 500 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-09-25 |
| Returned To Mfg | 2008-09-12 |
| Catalog Number | R4R9955 |
| Lot Number | H06H25046 |
| Device Expiration Date | 2011-08-31 |
| 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 | 2008-09-25 |