PRAIXAIR CO2 CYLINDER "3" CYLINDER NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-26 for PRAIXAIR CO2 CYLINDER "3" CYLINDER NA manufactured by Praxair.

Event Text Entries

[160524] At approx 12:30pm on july 12, 1999, a vascular shunt was placed in a pt for the purposes of dialysis. The procedure was successful and the pt was prepared to return to the nursing unit. The oxygen connection was removed from the wall oxygen source and attached to a portable cylinder. The oxygen cannula was then attached to the pt's existing tracheostomy. The pt was then transported by bed to the intensive care unit. The transport was completed within a few minutes. On arrival to the intesive care unit, the pt was noted to be in ventricular fibrillation. The pt then became apneic and sustained a cardiac arrest. Cardio-pulmonary resuscitation was implemented including medications (calcium and sodium bicarbonate) and intravenous fluids. The pt failed to respond and was pronounced dead after approx ten mins. At this time, it was discovered that the portable cylinder used to transport the pt was a carbon dioxide cylinder. The physician involved in the case concluded that the c02 had probably contributed to the pt's cardiopulmonary arrest. On examination, it was noted that the original tank used for transport was aluminum o2 tank with green paint near the top and the co2 tank was a steel container that was similar in color to the o2 tank that was originally used for transport to the operating room. The gunmetal gray color of the co2 tank was significantly distored by rust. In addition, the co2 tank contained a standardized (dept of transportation) green label that reads "non-flammable". This standard green label was located near the top of the tank where the green paint was located on the original aluminum oxygen cylinder. In addition, the co2 tank was equipped with a flowmeter and a green nipple adapter that was similar in appearance to the flowmeter normally used for oxygen. The regulators on the two canisters looked identical with the exception of the words "carbon dioxide" written in small print on the flowmeter portion. In essence, the pin indexing system that was designed to constrain this type of event was over-ridden by a look-alike product. Further review revealed that the color and type of oxygen tanks located in the facility were inconsistent. Tanks can be steel painted in light or dark green. They may also be aluminum (gray) in color with a green painted band at the top. The co2 tanks had a greenish haue with rust marks and scratches on them. Both have dept of transportation labels which have a green background. The vendor was notified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number233656
MDR Report Key233656
Date Received1999-07-26
Date of Report1999-07-13
Date of Event1999-07-12
Date Facility Aware1999-07-12
Report Date1999-07-20
Date Reported to FDA1999-07-22
Date Added to Maude1999-07-30
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 NamePRAIXAIR CO2 CYLINDER
Generic NameCARBON DIOXIDE "E" CYLINDER
Product CodeBXY
Date Received1999-07-26
Model Number"3" CYLINDER
Catalog NumberNA
Lot Number*
ID Number6LB70Z
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key226476
ManufacturerPRAXAIR
Manufacturer Address420 RIVER RD MODESTO CA 95351 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization 1999-07-26

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