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U.S. Department of Health and Human Services

Show #68, October 2007

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Show #68, October 2007

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 Recalls and Safety Alerts

October2007FDA Patient Safety News Homepage
Baxter Infusion Pumps Recalled because of Service Error (Video, print, and e-mail functions)
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Baxter Healthcare Corporation has recalled certain COLLEAGUE and FLO-GARD infusion pumps that were sent back to the company for service. These pumps may have been returned to users without the service being performed on them.

The recall initially involved over 500 COLLEAGUE and FLO-GARD pumps, but it has been expanded to include approximately 2000 more pumps with certain model and serial numbers (see links below under "Additional Information").

Check the serial numbers on FLO-GARD and COLLEAGUE pumps. If a pump is affected by this recall, the pump should be taken out of service and returned to Baxter for a repeat inspection and servicing. The company says it will provide free loaner units while pumps are being serviced. Baxter Healthcare Corporation can be reached at 1-800-THE-PUMP.

If a facility has sent back the units affected by this particular recall but is still using other COLLEAGUE pumps that did not get the upgrade, Baxter’s previous safety notices and FDA's Preliminary Public Health Notification should be reviewed for information about earlier Baxter infusion pump recalls.

Note that beginning in May 2007, some COLLEAGUE pumps got an upgrade that was cleared by FDA. These pumps are not part of this recall. The upgraded units can be identified by two plastic hang-tags that say "Power On" and "Battery." If a pump has those tags, it has been upgraded. The upgraded pumps also have a test-screen for the speaker that comes up when the power is turned on.

Additional Information:

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October2007FDA Patient Safety News Homepage
Stronger Warnings about Heart Failure for Certain Diabetes Drugs (Video, print, and e-mail functions)
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The manufacturers of thiazolidinedione drugs have strengthened warnings about the risks of heart failure with these medications, which are use to treat type 2 diabetes. They are sold as Avandia (rosiglitazone maleate), Avandaryl (rosiglitazone maleate and glimepiride), and Avandamet (rosiglitazone maleate and metformin hydrochloride), which all contain rosiglitazone, and Actos (pioglitazone hydrochloride), Duetact (pioglitazone hydrochloride and glimepride) and Actoplus met, which all contain pioglitazone.

The drug labels already had information about heart failure risk, but now there is a new boxed warning that re-emphasizes that these drugs may cause or worsen heart failure in certain patients, and stresses the importance of carefully monitoring patients for signs of heart failure.

The labeling recommends that after starting thiazolidinedione therapy or increasing the dose, patients should be observed carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema. If any of these signs and symptoms develop and heart failure is confirmed, practitioners should start appropriate management of the heart failure and consider stopping or reducing the dose of the drug. The boxed warning also notes that these drugs are not recommended for patients with symptomatic heart failure, and are specifically contraindicated in patients with NYHA Class III or IV heart failure.

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October2007FDA Patient Safety News Homepage
Recall of Certain Thoratec VADs (Video, print, and e-mail functions)
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Thoratec, a manufacturer of medical devices, is conducting two recalls related to its TLC-II ventricular assist device (VAD) systems.

One recall applies to TLC-II paracorporeal VADs manufactured between January 1, 2004 and October 2, 2006. The problem is with the collet nuts that connect the VAD to the inflow cannula. When these components were redesigned, the newer inflow cannula had a smaller diameter. If the newer cannula is used with the older design of collet nut, the cannula can disconnect from the pump and result in severe patient bleeding.

The older collet nuts for the inflow cannula are black in color, whereas the newer ones are white. The company says that black collet nuts should not be used with any VAD. Hospitals should make sure that all patients are using the redesigned white collet nut that is packaged with the redesigned inflow cannula.

The other recall affects the portable driver that can be used with the TLC-II VADs. This driver is a mobile unit that powers the blood pump when a patient is ambulatory and it can be used with either the paracorporeal or implantable VAD. The problem is that the driver's compressor motor may wear out much earlier than the expected 3000 hours of use. If that happens, the driver could stop working without warning, which would stop the patient's circulatory support.

This recall includes all drivers manufactured since September 2005. The company says that hospitals should check their current inventory and not use drivers with more than 1500 hours of use until they have been serviced. Hospitals should contact Thoratec to arrange for servicing.

Patients on VAD support with a TLC-II portable driver should immediately contact their hospitals to determine if their device is affected by this recall. Patients should also have a back-up driver and hand-pumps available at all times, and they or their caregivers should be trained in back-up procedures.

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October2007FDA Patient Safety News Homepage
Ongoing Review of Safety Data for Prilosec and Nexium (Video, print, and e-mail functions)
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December 11, 2007
UPDATE: FDA has now completed its' comprehensive review of known safety data for the drugs Prilosec (omeprazole) and Nexium (esomeprazole). FDA's conclusion continues to be that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that healthcare providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

October 2007
FDA is continuing to review new safety data for the proton pump inhibitors Prilosec and Nexium, which are used to treat severe gastroesophageal reflux disease (GERD).

These data came from two small long-term clinical studies where patients with severe GERD were assigned to be treated with Prilosec or Nexium or to receive surgery. The results raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in patients on drug therapy compared to those who received surgery.

After reviewing these studies, along with other information submitted by the company, FDA's preliminary conclusion is that taken together, these data do not suggest an increased risk of heart problems for patients treated with Prilosec or Nexium. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

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 Preventing Medical Errors

October2007FDA Patient Safety News Homepage
More Patient Deaths from Luer Misconnections (Video, print, and e-mail functions)
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A recent FDA article in the publication "Safe Practices in Patient Care" highlights the serious errors that continue to occur when different devices that use Luer fittings are mistakenly connected to each other. (NOTE: See link to complete article for FREE Continuing Education (CE) credit for nurses.)

Luer connectors, fittings and locks are widely used because they are inexpensive and easy to use. But the connector design also makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results.

Some of these incidents occurred when tubing from a portable blood pressure monitor was mistakenly connected to the patient's IV line, causing fatal air emboli. In another case, an air supply hose from a pneumatic compression device was inadvertently hooked up to a needleless IV tubing port.

The FDA article describes still other kinds of misconnections. For example, during a lithotripsy procedure, an ultrasonic lithotripter suction hose was incorrectly inserted into the roller pump. Instead of debris from the fractured stone being suctioned from the kidney, air was pumped into it. The hose was reconnected after the mistake was discovered, but the patient went into cardiac arrest and died shortly afterwards. And in yet another example, a patient misconnected her Foley catheter to her nasogastric (NG) tube. She was found with the Foley catheter disconnected from the drainage bag but with one end still in her bladder. The other end was connected to her NG tube, and urine was going into her stomach.

All these examples show that these misconnections can occur with a wide variety of devices, and in any clinical setting. In 2006, JCAHO responded to these kinds of events by issuing a Sentinel Event Alert. JCAHO's alert lists a number of recommendations to help prevent these kinds of mistakes. Here are some of them:

• Do not purchase non-IV equipment with connectors that can physically mate with a female IV Luer connector.

• Always trace a tube or catheter before connecting any new device or infusion.

• When a patient arrives in a new setting or service, as part of the hand-off process, recheck connections and trace all patient tubes and catheters to their sources.

• Inform non-clinical staff, patients, and their families that they must get help from clinical staff whenever their devices or infusions need to be connected or disconnected.

• Never use a standard Luer syringe for oral medications or enteric feedings.

• Be sure to emphasize the risk of tubing misconnections in orientation and training curricula.

Additional Information:

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October2007FDA Patient Safety News Homepage
Using the Wrong Exactacain Straws can Endanger Patients (Video, print, and e-mail functions)
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In a recent article, the Institute for Safe Medication Practices warned that using the wrong disposable straw with Exactacain can pose a safety risk to patients. Exactacain (benzocaine 14%, butamben 2%, tetracaine 2%). Exactacain is a local anesthetic spray which is used to numb patients' throats before endoscopy. It is delivered through a disposable straw that is inserted into a spray release button on top of the can.

The problem is that the manufacturer changed the spray release button last year, and that necessitated changing the diameter of the disposable straws that come packaged with the product. If the old red straws are used with the new spray cans, or the new clear straws with the old spray cans, a tight fit may not be achieved, and the straw could pop off into the patient's throat. This is especially dangerous, since the anesthetic dulls the gag reflex.

When using Exactacain, be sure to use only the straws that come with the bottle. Discard any leftover straws when starting a new bottle. And be sure to press the straw firmly into the hole in the spray applicator to get a tight fit.

The ISMP article reminds practitioners that using too much of a topical anesthetic spray can cause methemoglobinemia, which can lead to cyanosis and coma. ISMP says that the usual dose of Exactacain is three sprays, and that more than six should never be administered.

Additional Information:

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October2007FDA Patient Safety News Homepage
WHO Warns About Fatal Errors with Vincristine (Video, print, and e-mail functions)
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The World Health Organization (WHO) is alerting health professionals that despite repeated warnings, patient deaths continue to occur when the chemotherapy drug vincristine, which is intended for IV use, is accidentally given intrathecally. Patients on the receiving end of these accidents have died slowly and painfully.

WHO says that the "gold standard" in preventing these errors is to develop a lock-and-key design for needles, syringes, catheters, tubing and bags. This can prevent medications intended for IV use from being administered intrathecally, and vice versa. In the absence of a lock and key system, WHO recommends diluting IV vincristine and delivering it only in minibags, rather than in syringes. When diluting vincristine, use only normal saline or glucose in water, because vincristine is pH-sensitive. WHO says that vincristine labels should include a warning that says, "For intravenous use only. Fatal if given by other routes."

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 Advice for Patients

October2007FDA Patient Safety News Homepage
FDA Urges Caution on Giving Cough and Cold Medicines to Children (Video, print, and e-mail functions)
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FDA is urging parents to be careful when giving cough and cold medications to children, especially those younger than two. Serious and even fatal adverse events can occur if a child is given too much medicine, or it is given too often, or if the child is given more than one medicine that contains the same active ingredient.

Here are some recommendations for parents from the FDA:

• Do not give cough and cold products to children under 2 years old unless specifically directed to do so by a healthcare provider.

• Do not give children medicine that's made for adults. Only use products marked for babies, infants or children, which are sometimes labeled as "pediatric". Caregivers should be sure to read the "Drug Facts" box on the label to understand how to use the product and know the active ingredients and warnings.

• Do not give your child other prescription or non-prescription medicines at the same time as cough and cold medicines without first checking with your child's healthcare provider.

• Do not use kitchen utensils like a teaspoon or tablespoon to measure out liquid medicines. Instead, use the dropper, dosing cup or dosing spoon that comes with the medicine. If a measuring device is not included, buy one at a pharmacy and be sure it has markings that match the dosing recommendations on the drug label or given by your child's healthcare provider.

FDA will hold a public meeting in October to discuss the safety and effectiveness of cough and cold products for children.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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