MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-08 for CRYOCYTE FREEZING CONT. 250 MLW/LABEL POCKET R4R9953 manufactured by Baxter Healthcare.
[918846]
The customer contacted baxter healthcare to report that in 2008, when a cryopreserved autologous peripheral blood stem cell (pbsc) infusion was scheduled to take place for a patient, the cryocyte freezing container was thawed and spiked and 2/3rd of the contents spilled out when it was turned over due to a broken port. An unsuccessful attempt was then made to infuse the rest of the bag. Additional information received on 09/04/08 is as follows: autologous peripheral blood stem cells intended for re-infusion were the type of cells stored in the bag with a fill volume of 38ml. The bag was filled in early 2006 and thawed on original date. The technician was not exposed to the blood product as a result of the break. The break was described as a jagged break along the port seam. Per the customer, the patient received a total of 5. 75 cd34 x 106/kg and engraftment occurred on day 39 (late). The recommended dose of 5x106cd34/kg was met and the customer does not believe that the delayed engraftment was caused by the loss of cells. Per the customer's freezing, thawing, and storage protocol, a freezing press is used as well as a gordinier controlled -rate freezer. The bags are frozen in freeze presses and are stored in metal cassettes. An over-wrap is not used. The customer indicated that they were 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 sample is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8101374]
Sample is not available; therefore, an evaluation cannot be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00789 |
| MDR Report Key | 1156069 |
| Report Source | 05 |
| Date Received | 2008-09-08 |
| Date of Report | 2008-08-26 |
| Date of Event | 2008-03-12 |
| Date Mfgr Received | 2008-08-26 |
| Device Manufacturer Date | 2005-05-03 |
| Date Added to Maude | 2009-03-11 |
| 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 - RENAL DIVISION |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE FREEZING CONT. 250 MLW/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-09-08 |
| Catalog Number | R4R9953 |
| Device Expiration Date | 2010-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-08 |