CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2008-09-02 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare Corporation - Mountain Home.

Event Text Entries

[909691] The customer reported that a cryocyte freezing container split. The bag was ok when it was checked in the laboratory and was not dropped. The split occurred during handling prior to thawing. Volume of product frozen in this bag was 80ml. Cd34 selected cells were the types of cells stored in the bag. (b) (4). The nursing staff involved in this incident was adamant that the bag was not dropped. There have been no recent changes in protocol, critical equipment/supplies or personnel. Transplantation was performed in (b) (6) 2008. The clinicians were informed of the sterility testing showing positive for microorganisms. It is unknown to the customer if any additional antibiotics were given to the patient due to this event. The local complaint coordinator has indicated that there will be no further information available for this complaint.
Patient Sequence No: 1, Text Type: D, B5


[8195819] (b) (4) evaluation summary: the evaluation confirmed the reported problem. Upon visual inspection, a yellow note was attached to the bag over the cracks ending approximately 2 1/4" from the top of the bag. The crack extended to the lower right end of the hanger hole through the end seal of the bag up to approximately 2 1/4" from the top of the bag. Major branching emanating from a single point are a strong indication of impact or additional mechanical stress on the bag at the point. The customer did not report any type of dropping or obvious mechanical stress that might have caused this breakage. However, review of procedural parameters provided by the customer indicated that a protective cassette is not used for storage in vapor phase. Cryocyte freezing container labeling does recommend the use of a protective cassette for storage. It is not possible to confirm a root cause for this rupture. A review was performed on all batch record documents for the lot number involved, finding no issues during the manufacturing process or deviation from standard procedure. In addition, all units are 100% pressure tested during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423500-2008-00784
MDR Report Key1149544
Report Source01,06
Date Received2008-09-02
Date of Report2008-06-26
Date of Event2008-06-16
Date Mfgr Received2008-06-26
Device Manufacturer Date2006-12-04
Date Added to Maude2009-12-31
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 500 ML W/LABEL POCKET
Generic Name81KSE
Product CodeKSE
Date Received2008-09-02
Returned To Mfg2008-07-03
Catalog NumberR4R9955
Lot NumberH06L01032
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION - MOUNTAIN HOME
Manufacturer AddressMOUNTAIN HOME AR US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.