MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-09-02 for CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET R4R9957 manufactured by Baxter Healthcare.
[919141]
A customer contacted baxter to report that at the end of nitrogen liquid immersion, the technician heard a noise of "bursting" but nothing was observed visually (2 yellows caps were present). The frozen bag was inserted into a pouch and placed in a warm water bath. There was a second bursting sound but nothing was observed visually. The bag was then transferred under the hood to begin the cleaning step where the cellular product was transferred into a transfer bag with a transfer set in the chamber port (located in the middle of the cryocyte bag). The technician observed that the cap was present. During the transfer of the contents of the cryocyte into the transfer bag, the technician noted that at the second port chamber not used, the cellular product was in a small area located between the cap and the yellow d-ring, meaning that the cap was opened and present. Considering that this small area is sterile and the cap was present, the procedure was completed. There is no clinical consequence reported.
Patient Sequence No: 1, Text Type: D, B5
[8260315]
The evaluation of the actual sample involved revealed that although the customer did not observe any rupture visually as stated in the event description, when the yellow d-ring was removed, the membrane inside the membrane port was missing. During microscopic visual inspection, it was noted that the bag contained several small pieces of the membrane. It appears that the membrane separated from the port during the thawing process. It was not possible to confirm a root cause for this failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00783 |
| MDR Report Key | 1158303 |
| Report Source | 01,05,07 |
| Date Received | 2008-09-02 |
| Date of Report | 2008-08-26 |
| Date of Event | 2008-05-01 |
| Date Mfgr Received | 2008-08-26 |
| Date Added to Maude | 2009-02-18 |
| 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 |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| 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 750 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-09-02 |
| Returned To Mfg | 2008-05-30 |
| Catalog Number | R4R9957 |
| Lot Number | H06J27031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-02 |