Draeger Jaundice Meter Recalled by FDA
Draeger Medical Systems, Inc. has issued an urgent recall on the company’s Jaundice Meters JM-103 and JM-105 bearing product code MQM. The U. S. Food and Drug Administration (FDA) notified consumers in June of 2018. The FDA determined that the recall must be a Level 1 recall, which is the highest, most urgent recall standard. The jaundice meters subject to this recall display reading which may be false or inaccurate. The incorrect readings can place a newborn child at tremendous risk of death or severe illness if doctors misdiagnose jaundice in newborns. Consequently, physicians, medical centers, and hospitals who continue to use these products place children at an unreasonable risk of suffering adverse health risks or dying.
Consumer Advocates Parker Waichman LLP Warn of the Potential Devastating Consequences of Using this Defective Medical Device
Parker Waichman LLP is a plaintiffs’ law firm who is committed to fighting for the rights of all people injured by the negligence of another. Parker Waichman’s defective medical device attorneys have fought large medical device manufacturers like Draeger and won substantial damages award for their clients. Parker Waichman’s track record speaks volumes of the tremendous success they have had recovering damages for their clients. To date, Parker Waichman has recovered more than $2 billion in financial compensation for injuries and deaths caused by defective medical devices and the companies who negligently manufacturer them.
Draeger Class I Recall
Draeger’s Class I recall of their JM-103 and JM-105 jaundice meters pertain to their failure to accurately measure the amount of “yellowness in the soft tissues” of infants. The technical term for a jaundice meter is a bilirubinometer. Draeger intended the jaundice meter to measure the amount of bilirubin in a newborn’s blood by analyzing the amount of “yellowness of the subcutaneous tissue” present in the child. Although jaundice is reasonably common among newborns and reverses itself within a few days, failing to treat the problem correctly could cause the child to suffer severe health problems or delay treatment for emergent health concerns.
The recall stems from readings that clinicians misinterpreted. Draeger mailed notices to its customers in March of 2018 warning the consumers that medical personnel were mistaking the results of testing. The company sent an “Urgent Medical Device Safety Notice” in May on or about May 15, 2018, as well. The company determined that the labeling on the device was insufficient because it was ambiguous as to what specific signals emitted by the machine indicated. The FDA suggests in its recall notice that numerous children were seriously hurt because the ambiguous readings lead to treatment of perceived symptoms deemed inaccurate due to the misinterpreted readings. Furthermore, the FDA attributes the recall to a device design failure.
Draeger’s bilirubinometers read levels of bilirubin in the child within certain limits. Each device displays a coded message when the machine read bilirubin levels that exceed the device’s limits to analyze. In the JM-103, the device flashes a signal on its display of three dashes (- – – ) when the bilirubin contained in the child’s blood exceeds the machine’s ability to read it. Similarly, the JM-105 flashes a dash-zero-dash (-0-) when the bilirubin in the blood exceeds the maximum levels of analysis and is out of measurement range.
Misinterpretation of the readings can lead to devastating health consequences. Many practitioners read the measurements as a low or “zero” reading even though the opposite was true. Therefore, the medical practitioners denied or delayed critical medical interventions because of the misinterpreted reading.
The FDA determined that the displays be neither clear nor “intuitive.” Draeger endeavored to correct the problem by clarifying the intended interpretation of the display readings by upgrading labeling. Draeger insists that the user should attach the correct labels to the device. Proper labeling, in theory, ensures that the user has readily accessible reference material to which he or she could refer if the user questions the display reading. Draeger indicated that managers or supervisors of users must take the appropriate steps to ensure that their medical assistants receive proper training to interpret the readings correctly for measurements out of the screening range of the instrument.
The inherent problem with the device is that the instrument is a screening device. Draeger never designed the device with the intention of users employing the device as a primary method of diagnosing hyperbilirubinemia. Draeger never made its purpose clear when the company initially released the product. Consequently, Draeger’s attempts to remediate damage to infants in conjunction with clarified labeling is to instruct users that the JM-103 and JM-105 models are merely for screening purposes and not as a diagnostic device. Draeger counsels JM-103 and JM-105 consumers to seek confirmatory test results before concluding their patient’s bilirubin level.
Draeger widely distributed its jaundice meters subject to the recall. The FDA recall notice indicates that Draeger distributed its jaundice meters all across the United States and worldwide.
Consequences of Misreading Bilirubin Results
Infants suffering from hyperbilirubinemia are at risk for experiencing severe health problems. The FDA warns medical personnel that babies with jaundice may suffer brain damage or death in certain circumstances. Jaundice occurs in newborns when the bilirubin levels in the blood are high. Bilirubin is a yellow substance that replaces old blood cells. The liver metabolizes bilirubin and excretes it through the stool. Jaundice occurs within the first week of life but could occur after three weeks after birth.
Slightly elevated bilirubin levels in newborns are common. The mother’s placenta replaces the child’s aged blood cells while the child is growing in the womb. After the child is born, the liver frequently needs some time to commence the process of removing bilirubin from the blood. Most cases of hyperbilirubinemia resolve within a couple of days and are not a danger to healthy newborns that are born after a full-term pregnancy. However, jaundice accompanied by a fever is indicators of a substantial health problem. Additionally, a medical emergency could be indicated by the presence of jaundice, fever, listlessness, and poor feeding habits. Parents must seek emergency medical attention for their child if these symptoms are present.
The possible adverse health consequences for premature children and babies born with health problems are at an elevated risk for complications caused by hyperbilirubinemia. At-risk children could develop complications from hyperbilirubinemia such as:
- Cerebral palsy,
- Deafness, and
- Kernicterus, which is brain damage.
Kernicterus occurs in children with extremely high levels of bilirubin. The bilirubin collects in the brain instead of being removed through the liver.
Dangers of Defective Medical Devices
Considering the substantial health consequences a child might suffer if medical personnel delay or withhold treatment for hyperbilirubinemia, Draeger could be liable for manufacturing a defective medical device. Kernicterus is an irreversible brain injury which can cut a child’s life tragically short. Additionally, cerebral palsy is a chronic disease that shortens lifespans of its victims. Moreover, deafness from birth will deprive a growing child of many joys in life such as learning to speak, hearing their parents’ voices, listening to music, and engaging in regular human communication. Also, the parents of a sick child will experience significant financial stain and substantial emotional distress because Draeger produced a defective medical device. As a result, you need a litigation attorney who understands how to maximize your potential financial recovery for you and your child.
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