CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET R4R9957

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1423500-2008-00783
MDR Report Key1158303
Report Source01,05,07
Date Received2008-09-02
Date of Report2008-08-26
Date of Event2008-05-01
Date Mfgr Received2008-08-26
Date Added to Maude2009-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKAREN KIRBY, MANAGER
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704541
Manufacturer G1BAXTER HEALTHCARE CORPORATION
Manufacturer Street1900 HIGHWAY 201 NORTH
Manufacturer CityMOUNTAIN HOME AR 72653249
Manufacturer CountryUS
Manufacturer Postal Code72653 2497
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET
Generic Name81KSE
Product CodeKSE
Date Received2008-09-02
Returned To Mfg2008-05-30
Catalog NumberR4R9957
Lot NumberH06J27031
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE
Manufacturer AddressMOUNTAIN HOME AR US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-02

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