TAYLOR-WHARTON K SERIES *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for TAYLOR-WHARTON K SERIES * manufactured by Taylor-wharton.

Event Text Entries

[15034278] Sometime in august/september 1995, condensation built up inside the freezer causing the lid to be frozen in place above the normal position. Consequently the lid was replaced. In march 1997, the lid replacement began to show signs of lifting with accumulated ice build-up. A new freezer was ordered and transfer of bone marrow product initiated on 5-9-97. During the process of transferring product to the new freezer it was noted that some of the product bags had leaked and now contained liquid nitrogen. During month of april 1997, freezer alarm would go off indicating need for more liquid nitrogen.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number109526
MDR Report Key109526
Date Received1997-07-03
Date of Report1997-05-30
Date of Event1995-01-01
Date Facility Aware1997-05-12
Report Date1997-05-30
Date Reported to Mfgr1997-06-02
Date Added to Maude1997-08-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTAYLOR-WHARTON
Generic NameLIQUID NITROGEN STORAGE FREEZER
Product CodeJRM
Date Received1997-07-03
Model NumberK SERIES
Catalog Number*
Lot Number*
ID NumberPART # 17K
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age12 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key107655
ManufacturerTAYLOR-WHARTON
Manufacturer Address1505 N MAIN ST INDIANPOLIS IN 46224 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-07-03

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.