MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-10-31 for CRYOCYTE FREEZING CONTAINER 250 ML W/LABEL POCKET R4R9953 manufactured by Baxter Healthcare.
[957257]
A cryocyte container cracked after thawing. Additional information received. The product was not administered. There was a loss of about 0. 5 million cd34 cells, but they were still able to infuse 1. 5 million. Autologus bone marrow was being processed/stored. It was to early to tell if the pt engrafted as expected. The bag had a fill volume of 50ml and was filled in 2007. The date the bag was being thawed was 2008, and the rupture was found on that date. The customer stated that there was no damage or deviation from the standard procedure during filling, freezing, storage, transport, and thawing.
Patient Sequence No: 1, Text Type: D, B5
[8212389]
Baxter medical director assessment: this is a cryocyte bag breakage that occurred during/after thawing. There is no information of any pt adverse outcomes at this time. The product in the broken bag was not infused; so there is no risk regarding 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 patient at greater risk, with a possibility of infection. As such, this breakage could potentially cause or contribute to an event. An attempt should be made, if possible, to obtain the pt outcome. Multiple attempts have been made to acquire information concerning the pt's outcome. No response has been received. Cryocyte bag breakage is currently being address through capa.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954761-2008-00051 |
| MDR Report Key | 1220093 |
| Report Source | 06 |
| Date Received | 2008-10-31 |
| Date of Report | 2008-10-31 |
| Date of Event | 2008-10-02 |
| Date Mfgr Received | 2008-10-02 |
| Device Manufacturer Date | 2007-11-20 |
| 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 250 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-10-31 |
| Catalog Number | R4R9953 |
| Lot Number | H07K01033 |
| Device Expiration Date | 2012-11-30 |
| 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 |