Observe the CGMP's or Else…
On May 24, 1983, a large welding supply company in the southeast, delivered and connected a VGL thought to contain medical oxygen to a local hospital. During the course of the evening, the product was administered to a premature infant, a 46 year old male, and a 27 year old female in three different areas of the hospital and all three died. Analysis of the gas found that the alleged oxygen was in fact argon. To further complicate matters, the VGL was partially labeled "Liquid O," had a second label on the other side which read argon, and the fill line had an argon fitting while the discharge line had an oxygen fitting.
In 1987, a large welding supply company located in the northeast, jury-rigged four oxygen cylinders which were painted gray, and placed CO2 into these cylinders. However, the cylinders bore a proper Oxygen U.S.P. label, and had the correct CGA 540 oxygen valve. Four of the cylinders were subsequently sent to a hospital and administered to two patients undergoing surgery. One patient's death was attributed to carbon dioxide exposure while the other patient was seriously injured.
On December 20, 1993, a home care company located in the northeast and filling liquid oxygen only, had it's employee go to their supplier to pick up a GP-45 of Oxygen U.S.P. The supplier's employees were too busy to accompany the home care company's employee to the loading dock, so they authorized the employee to go to the loading dock and select one of the GP-45s. Unfortunately, the employee selected a GP-45 of argon instead of Oxygen U.S.P. Although a certificate of analysis was provided, no testing was performed and the labeling was not examined. The employee loaded the vessel into the van and went to three patients homes to fill their vessels, however, the employee encountered a problem. When he went to fill the cryogenic home vessels, the discharge line was not compatible with the vessels fittings. So he took a fitting from a spent oxygen vessel and installed it on the GP-45, he could now fill the patients cryogenic vessels with the deadly product. Luckily, the next day, the employee became aware of the argon mix-up and retrieved all three vessels with no injuries. Fortunately, these three patients were not dependent on high inspired oxygen concentrations.
In March 1996, the FDA received a report of eleven deaths associated with contaminated oxygen being delivered to a VA hospital in the southwest. According to the report, a large storage tank was being replaced, and a temporary 500 gallon cryogenic vessel was brought in and connected to the hospitals main oxygen system via a 50 foot hose. A subsequent analysis of the 50 foot hose tested positive for the presence of trichloroethylene, a standard cleaning chemical, but very toxic to humans.
On December 2, 1996, a children's home located in New York reported adverse reactions experienced by nine patients due to the inhalation of carbon dioxide, instead of oxygen. FDA investigation found the firm supplying the medical grade product had included a cryogenic vessel of industrial grade carbon dioxide. An employee of the home went to attach a cryogenic vessel of Oxygen U.S.P. and unfortunately selected the carbon dioxide vessel, and he failed to examine the label. He noted the fittings on the carbon dioxide vessel weren't compatible with the connector on their oxygen system, so he removed an oxygen fitting from an empty oxygen vessel and installed it on the carbon dioxide vessel. He then introduced the carbon dioxide into the oxygen system. Two of the patients were injured critically, four experienced varying stages of respiratory distress, and three were not affected.
In October 1997, the FDA received a second report similar to the New York children's home. However, this time there was a report of a death occurring at a Nebraska hospital due to the inhalation of argon. The hospital received a shipment of Oxygen U.S.P. in cryogenic vessels, and included in the delivery was a cryogenic vessel of argon. The hospital was running low on oxygen and sent a maintenance man to connect a new oxygen supply vessel to their system. He selected the argon vessel, failed to examine the label, and was unable to connect the vessel to the oxygen system. He removed the fitting from an empty oxygen vessel, installed it on the argon vessel, and was then able to connect the deadly product to the oxygen system. Argon was administered to a patient who was undergoing minor surgery, and died.
On April 22, 1998, The FDA received their third report from a hospital in 3 years. A hospital located in Idaho discovered a large cryogenic vessel of industrial grade nitrogen had been connected by the supply firm's driver to their oxygen system which supplied the operating rooms, labor and delivery rooms, and the emergency room. When the driver was unable to connect the incompatible nitrogen vessel outlet fitting, he disconnected the nitrogen fitting and replaced it with the appropriate oxygen fitting so that it could be connected to the oxygen system. Unfortunately, two deaths followed the administration of the toxic industrial product.
Medical Oxygen Analysis in Transfill Applications
Medical Applications for Oxygen Analysis
Here are some of our featured products of note:
[Oxigraf O2T] O2 analyzer for transfill (oxygen refilling)
[Oxigraf O2iM] Fixed oxygen deficiency monitor (ODM)