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 report with the FDA on 2008-08-21 for CRYOCYTE FREEZING CONTAINER 750 ML W/LABEL POCKET R4R9957 manufactured by Baxter Healthcare.

Event Text Entries

[931776] This is a case report from baxter that refers to a cryocyte container. During the thawing step, the bag was found cracked and the product was lost. The graft proceeded and succeeded with other available bags. There were no clinical consequences reported. Additional information received indicates that the type of cells stored in the bag were cord blood stem cells. Fill volume was 151ml and the date of fill was in 2008. The technician was not exposed to the blood product as a result of the break. The break was at the bottom of the bag. Per the freezing, thawing, and storage protocol: a freezing press is not used, a nicool plus freezer is used, and the bags are frozen at a specific controlled rate. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[8107322] The actual sample was not available for evaluation. However, photographs are available and a visual evaluation will be performed based on those. A follow-up report will be submitted when this evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423500-2008-00758
MDR Report Key1137748
Report Source01,05
Date Received2008-08-21
Date of Report2008-08-01
Date of Event2008-04-29
Date Mfgr Received2008-08-01
Date Added to Maude2008-11-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKAREN KIRBY, COMPLIANCE MGR.
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 Received2008-08-21
Catalog NumberR4R9957
Lot NumberH00G10046
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1269647
ManufacturerBAXTER HEALTHCARE
Manufacturer AddressMOUNTAIN HOME AR US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-08-21

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