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Posts Tagged ‘Death’

Serious Complications with Negative Pressure Wound Therapy (January 2010)

Friday, February 12th, 2010

Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010

FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from the wound area. NPWT is used in both acute and long-term care facilities and at home.

FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Although rare, complications can occur wherever these systems are used. Most of the deaths occurred at home or in a long-term care facility. Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports. Other serious effects included worsening infection of the original open wound, retention of foam dressing pieces, or foam adhering to tissues or becoming imbedded in the wound.

FDA has several recommendations to help reduce the risk of serious complications with Negative Pressure Wound Therapy. Here are some of them:

• Select patients carefully. This therapy is contraindicated in patients with exposed vasculature, nerves, organs and anastomotic sites, and also for patients with untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and necrotic tissue with eschar present. Also, carefully consider the use of this therapy in patients with certain risk factors, including those with a high risk for bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.

• Assure that the patient is monitored frequently by a trained practitioner in an appropriate care setting.

• Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

• Finally, if the patient is a candidate for using a Negative Pressure Wound Therapy system at home, instruct the patient and any caregivers about how to use the system and ask them to demonstrate their understanding. Make sure they know the signs and symptoms of potential complications and what to do if they occur.

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Tags: Bleeding, Death, FDA, Infection, Negative Pressure Wound Therapy, NPWT, Patient Safety
Posted in Consumer Awareness, FDA Information, Lawbits, Personal Injury Lawsuit | 1 Comment »

Warning Against Nebulizing Relenza Inhalation Powder (January 2010)

Thursday, February 4th, 2010

Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010

GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophylaxis of influenza, is only intended to be inhaled using a Diskhaler.

In a recent letter, the company notes that some practitioners have dissolved Relenza Inhalation Powder in various solutions. Using a mechanical ventilator, they then delivered the drug in nebulized form to patients who could not take oral influenza medications or could not inhale the drug using a Diskhaler.

The letter describes the death of a pregnant woman with influenza who was treated with Relenza Inhalation Powder that had been solubilized and administered by mechanical ventilation. The patient’s death was attributed to obstruction of the ventilator, possibly from stickiness caused by lactose in the Relenza Inhalation Powder.

The letter reminds practitioners that the safety, effectiveness and stability of Relenza Inhalation Powder have not been established for nebulization, that this use has not been approved by the FDA, and that this drug should only be administered using the Diskhaler device that comes with it.

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Tags: Death, Diskhaler, FDA, GlaxoSmithKline, Influenza, Nebulizing, Patient Safety, Relenza Inhalation Powder, Ventilator
Posted in Consumer Awareness, FDA Information, Influenza, Lawbits, Personal Injury Lawsuit, Pharmaceutical Lawsuits, Product Liability Lawsuit | No Comments »

Alert on Philips Avalon Fetal Monitors (January 2010)

Thursday, January 21st, 2010

Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010

Philips Healthcare is recalling the company’s Avalon fetal monitors because of an increase in inaccurate readings. As a result, users may fail to identify fetal distress, fail to perform needed interventions, or perform unnecessary interventions such as cesarean delivery. All of these could result in serious injury or death to the mother and fetus.

Increased inaccuracies have included switching between the fetal and maternal heart rates, doubling or halving of the fetal heart rate, false decelerations, a mismatch between the audible and printed readings, and noisy or erratic signals.

The affected models are the FM20, FM30, FM40 and FM50. Philips is not removing them from the market at this time. While the company continues to investigate this situation, it recommends several interim steps to reduce the likelihood of inaccurate readings or their impact.

These include using the monitor’s cross-channel verification feature to differentiate between the fetal and maternal heart rates, and, when in doubt, confirming the fetal heart rate with ultrasound imaging or fetal scalp electrodes.

The company also recommends that users recognize situations that can increase the likelihood of inaccurate readings. These include contractions, maternal tachycardia, fetal or maternal movement, and maternal pushing, coughing or vomiting.

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Tags: Death, FDA, Fetal Distress, Inaccurate Readings, Patient Safety, Philips Avalon Fetal Monitors, Serious Injury
Posted in Consumer Awareness, FDA Information, Hospital Device Recall, Lawbits, Medical Errors, Personal Injury Lawsuit, Product Liability Lawsuit, Recall | No Comments »

Never Use Parenteral Syringes for Oral Medications (January 2010)

Wednesday, January 20th, 2010

Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010

A recent report by the Institute for Safe Medication Practices says that despite past warnings, serious medical errors continue to occur when parenteral syringes are used to administer oral medications. The underlying problem is that once a parenteral syringe is filled with a liquid intended for oral use, it can be accidentally connected to an intravenous line. That’s why oral syringes should always be used for oral medications because they can’t readily be connected to an IV line and can’t accommodate a needle.

ISMP describes several cases in which oral medications were prepared in a parenteral syringe and accidentally given intravenously. In one case, a week-old infant died after an intermittent feeding was prepared in a parenteral syringe and administered intravenously instead of through a nasogastric tube. In another case, a nurse prepared yogurt in a parenteral syringe, intending to give it through an enteral tube to treat diarrhea. The patient had both an enteral and PICC line, both of them unlabled, and the nurse accidentally administered the yogurt through the PICC line.

In still another case, Versed and Tylenol liquids were withdrawn into a parenteral syringe, to be given orally to a child being prepared for surgery. When the nurse in charge was called away, a student nurse gave the drugs intravenously. The child was unconscious for nearly an hour and required several days of antibiotics. In these cases and others, it took only a momentary mental lapse to connect a parenteral syringe containing an oral liquid to the wrong line -- sometimes with fatal results.

ISMP points out that it is not enough to have the pharmacy dispense oral liquids in a unit-dose cup. In some cases, nurses have withdrawn the liquid from the cup into a parenteral syringe and then administered the dose intravenously.

ISMP stresses that all patient care and procedure units should be supplied with oral syringes, even if they are used infrequently, and nurses need to understand the importance of using them. They should carry an auxiliary label that prominently says, “for oral use only.”

ISMP’s alert features a ten-point strategy for promoting the use of oral syringes in healthcare facilities.

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Tags: Death, FDA, Intravenous Lines, Medical Errors, Oral Medications, Parenteral Syringes, Patient Safety
Posted in Consumer Awareness, FDA Information, Lawbits, Medical Errors, Personal Injury Lawsuit | No Comments »

Alaris Medley Infusion Systems Recalled (October 2009)

Monday, October 12th, 2009

Video originally created by FDA -- posted by Lawsuit.com on October 6, 2009

CareFusion is alerting healthcare professionals about a number of safety problems with several models of Alaris infusion systems. These problems could cause patients to be over or under-infused, which could lead to serious injury or death.

Certain units of the following Alaris devices are affected:

•Point-of-care Units, Models 8000 and 8015

•Pump Module, Model 8100

•Patient-Controlled Analgesia Module, Model 8120

•Inter-Unit Interface Connectors for the Alaris System

These devices were formerly sold under the “Medley” name.

The company notified customers about these potential problems in June, and described its plans to provide software and hardware corrections over the next several months. Until then the company’s notice advises pump users to take certain steps to mitigate the problems.

For example, one failure can affect the Alaris PC unit when it is used with the PCA module. The pump is supposed to verify that the volume of medication in the syringe will deliver the infusion that is programmed. But if the infusion rate exceeds the volume of therapy in the syringe, a warning is displayed. If the pump user confirms the infusion and the patient presses the button on his handset to deliver medication, the pump may deliver the entire contents of the syringe to the patient, which could cause serious injury or death.

The company says that if the syringe volume warning appears, you must first take the dose request handset from patients to keep them from pressing the button. Then, press the CONFIRM key, then the PAUSE key to halt the infusion. Remove the syringe, verify the concentration, and reprogram the infusion. Do not return the handset to the patient until you have reprogrammed the infusion and confirmed that it’s been programmed properly.

Another example involves the possible failure of the circuitry that protects against electrostatic discharge in certain Alaris PC units. Because of this, there could be problems with the entry keypad, including the possibility that the keypad could not respond to key presses, or that key entries could register incorrectly or could occur without keys being pressed. Pump users should always verify the drug name, concentration, and programmed infusion parameters before starting an infusion. If a keypad does not perform correctly, take the pump out of service and return it to the company.

You can get more information about the Alaris System recall by calling the CareFusion recall center at 888-562-6018.

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Tags: Alaris Infusion Pumps, Death, FDA, Patient Safety, Recall, Serious Injury
Posted in Consumer Awareness, FDA Information, Hospital Device Recall, Lawbits, Personal Injury Lawsuit, Product Liability Lawsuit, Recall | No Comments »

Posts Tagged ‘Death’

Serious Complications with Negative Pressure Wound Therapy (January 2010)

Warning Against Nebulizing Relenza Inhalation Powder (January 2010)

Alert on Philips Avalon Fetal Monitors (January 2010)

Never Use Parenteral Syringes for Oral Medications (January 2010)

Alaris Medley Infusion Systems Recalled (October 2009)

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