MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-12 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare.
[964169]
The customer contacted baxter healthcare to report a cryocyte bag breakage. Additional info received from the customer on 09/09/08 is as follows: the type of cells stored in the bag were hematopoietic progenitor apheresis cells (hpc) intended for patient use with a fill volume of 40ml. The fill date was (b) (6) 2008. Following the break, which was noticed during thawing, the cells were placed in a -80 degree c mechanical freezer. The break was described as being a small break at the seam of the bag. As the sample is available for evaluation, the customer indicated that all viral markers are negative. As a result of the break, the customer indicated that the patient received a reduced dose of 3. 37 x 10e6 cd34+/kg when the intended dose was 3. 87 x 10e6 cd34+/kg. 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, or transport. The customer did indicate that the laboratory started storing frozen hpc, apheresis products in vapor phase of nl2 at<-150 degrees c on (b) (6) 2006.
Patient Sequence No: 1, Text Type: D, B5
[8097918]
(b) (4). The sample has been reported to be available and has been requested. A follow-up report will be submitted when evaluation of this sample has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00798 |
| MDR Report Key | 1169734 |
| Report Source | 05 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-08-08 |
| Date of Event | 2008-08-07 |
| Date Mfgr Received | 2008-09-09 |
| Device Manufacturer Date | 2008-01-25 |
| 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 RT 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 N |
| 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 | 2008-09-12 |
| Catalog Number | R4R9955 |
| Lot Number | H08A03103 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-12 |