MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2008-10-31 for CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET R4R9957 manufactured by Baxter Healthcare.
[16120176]
Baxter medical director assessment: this is a cryocyte bag leakage that occurred during/after thawing. There is no information of any pt adverse outcomes at this time. The customer site has refused to provide any additional pt information. As we do not know if the pt was infused with product we are unable to assess the risk of a break in sterility and a resulting infection due to the product being exposed to the outside atmosphere. As in all cases of cryocyte bag breakages during/after thawing there is the potential of loss of engraftment or delay in engraftment with the loss of product. This puts the pt at greater risk, with a possibility of infection. As such, this breakage could potentially cause or contribute to an event. As the customer site has refused to provide any additional information there is no further investigation necessary. Cryocyte bag breakage is currently being addressed through capa.
Patient Sequence No: 1, Text Type: N, H10
[16170468]
During the thawing of the bags at 37 degree celsius customer recognized that cryocyte bags were leaking. The bags split along the seam. Four bags were affected. The units were stored in liquid nitrogen for 15 days; 150ml of stem cells were being stored. No freezing press was used to remove air. The customer has refused to give any additional data surrounding the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954761-2008-00052 |
| MDR Report Key | 1220094 |
| Report Source | 01,06 |
| Date Received | 2008-10-31 |
| Date of Report | 2008-10-31 |
| Date of Event | 2008-09-26 |
| Date Mfgr Received | 2008-10-02 |
| Date Added to Maude | 2009-07-09 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSHUA LEACH, SENIOR SPECIALIST |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723250 |
| Manufacturer G1 | BAXTER HEALTHCARE |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| 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 | 2008-10-31 |
| Catalog Number | R4R9957 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-31 |