MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-27 for CRYOCYTE PACK R4R9953 manufactured by Baxter Healthcare - Mountain Home.
[16013034]
It was reported by a customer she had an issue with one cryocyte freezing container. The customer stated that cord blood was frozen in the container on (b)(6) 2009 and the bag cracked upon thawing prior to patient infusion. This lead to a loss of product and potentially compromised the sterility. There was no patient injury or medical intervention reported with this event.? No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[16386206]
(b)(4). Baxter medical assessment: this is a cryocyte bag breakage that was discovered. There have been no reported negative clinical consequences for the patient. As in all cases of cryocyte bag breakages during storage there is the potential of loss of engraftment or delay in engraftment with the loss of product. This puts the patient at greater risk. As such, a breakage could potentially cause or contribute to an event if it were to reoccur. Please know this product is end of life. A follow-up report will be submitted upon receipt and evaluation of additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2014-02653 |
| MDR Report Key | 3593864 |
| Report Source | 06 |
| Date Received | 2014-01-27 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 2008-05-09 |
| Date Added to Maude | 2014-03-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIMBERLY CRANE |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723182 |
| Manufacturer G1 | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Street | 1900 N HIGHWAY 201 |
| 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 PACK |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS |
| Product Code | KSR |
| Date Received | 2014-01-27 |
| Catalog Number | R4R9953 |
| Lot Number | H08E08079 |
| Device Expiration Date | 2013-05-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Address | 1900 N HIGHWAY 201 MOUNTAIN HOME AR 72653 US 72653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-27 |