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U.S. Department of Health and Human Services

MedSun: Newsletter #29, October 2008

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Newsletter #29, October 2008

Articles

Cutting a Battery Pack Cable Can Start a Fire

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By Nasrin Mirsaidi, RN, CNOR, MSN - Reprinted from August Nursing2008, Volume 38, Number 8, Pages 13-14

FDA Medical Device Safety Page

Cutting a battery pack cable can cause short circuits. In turn, can cause the batteries to discharge rapidly and produce intense heat and flammable gases. No serious injuries resulted but when explosions occur patients and staff are at risk. This article provides recommendations to avoid the risks of sparks, fires, toxic fumes and explosions.

Additional Information:

Cutting a Battery Pack Cable Can Start a Fire. By Nasrin Mirsaidi, RN, CNOR, MSN – Reprinted from August Nursing2008, Volume 38, Number 8, Pages 13-14. FDA Medical Device Safety Page.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm064603.htm

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Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA

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Medical Device Reporting (MDR) is the mechanism by which the FDA receives significant medical device adverse events from manufacturers, importers and user facilities (e.g., hospitals, nursing homes), in order to detect and correct the problems http://www.fda.gov/cdrh/mdr/mdr-general.html. This information is used to protect the public health as well as ensure that devices are not adulterated or misbranded and are safe and effective for their intended uses. If you are a consumer or health professional you should use the MedWatch program at http://www.fda.gov/medwatch/ for reporting significant adverse events or problems with medical products. This Reporting Tip is meant to clarify how health professionals can best report an adverse event that occurs with a reprocessed single use device to the FDA.

What is a Single Use Device (SUD)?

An SUD is a device that is intended for one use on a single patient during a single procedure. (See Medical Device User Fee and Modernization Act of 2002, Public Law 107-250, Title III, Section 302).

What is a reprocessed SUD?

A reprocessed SUD is one that has been used on a patient and subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. (See Medical Device User Fee and Modernization Act of 2002, Public Law 107-250, Title III, Section 302).

What are common examples of reprocessed SUDs?

Some examples include: pneumatic compression sleeves, surgical blades, bits and burrs, trocars and electrophysiology (EP) catheters.

How should information about the reprocessor be noted when reporting a problem with a reprocessed SUD to the FDA through MedWatch?

Third party firms and hospitals reprocessing SUDs are part of the same regulatory framework as original equipment manufacturers (OEMs) and their products and quality processes must meet prescribed standards. For this reason, when you report a problem with a reprocessed SUD you should list the reprocessor as the manufacturer of the device. For more information about how to fill out the device section of a MedWatch form go to http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm#E3

Where should defective reprocessed SUDs be sent for evaluation?

When a defective product, or one which may have been involved in a death or serious injury, is to be returned for evaluation, be sure that you return it to the reprocessor, not to the original manufacturer of that device.

The FDA is interested in reports on reprocessed single use devices and their performance in the clinical environment.

Additional Information:

For general information about reporting medical device adverse events, go to:
http://www.fda.gov/cdrh/mdr/mdr-general.html

For more information about reprocessed single use devices go to:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm

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Interventional Fluoroscopy: Reducing Radiation Risks

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National Cancer Institute
Interventional fluoroscopy is an increasingly important and valuable tool for treating disease, but it is not without risk. It is important for the health care community, manufacturers and regulators to work together to optimize patient radiation dose. Physicians must continuously think about optimizing radiation dose to the patient. Used prudently and optimally, interventional fluoroscopy is one of the valuable treatment modalities for a wide variety of diseases and disorders. The link to a related MedSun report can be found under “Additional Information” below.

Additional Information:

Interventional Fluoroscopy: Reducing Radiation Risks. National Cancer Institute.
http://www.cancer.gov/images/Documents/45bae965-697a-4de8-9dae-b77222e0e79d/InterventionalFluor.pdf

MedSun Report:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D%5F7%25O8%20%0A&CFID=8234698&CFTOKEN=64567deb8af08aa8-6E98FCE4

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Misprogramming PCA Concentration Leads to Dosing Errors

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Institute for Safe Medication Practices (ISMP)

ISMP has received a small but concerning number of reports of overdoses with patient controlled analgesia (PCA) due to pump programming errors. Although every aspect in the PCA process has the potential for an error, ISMP is especially concerned about errors related to programming the concentration of the narcotic. Accidentally entering a higher than actual concentration of narcotic in the PCA pump results in the delivery of a lower PCA dose than prescribed. This article offers recommendations to help prevent these errors.

Additional Information:

Misprogramming PCA Concentration Leads to Dosing Errors. Institute for Safe Medication Practices. August 28, 2008.
http://www.ismp.org/Newsletters/acutecare/articles/20080828.asp

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Proper Positioning of Pharmacy Label on Hospira PCA Vials will Avoid Interference with Scanning

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Institute for Safe Medication Practices (ISMP)

A 22-year-old male patient admitted to the hospital following a motor vehicle accident received an overdose of fentanyl and experienced respiratory arrest which, fortunately, was reversed with naloxone. The patient had been receiving fentanyl via a Hospira LifeCare patient-controlled analgesia (PCA) pump (see Figure 1 in the PDF version of the newsletter). The overdose was unrelated to the way the drug was prescribed or any device malfunction. Instead, it was associated with the way pharmacy applied labels after preparing fentanyl PCA doses using the pump’s compatible empty sterile glass vials. This article provides safe practice recommendations to prevent these errors.

Additional Information:

Proper Positioning of Pharmacy Label on Hospira PCA Vials will Avoid Interference with Scanning. Institute for Safe Medication Practices (ISMP). August 14, 2008.
http://www.ismp.org/Newsletters/acutecare/articles/20080814.asp

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FDA Clears Test to Help Doctors Manage Heart Transplant Patients

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FDA Press Release

The U.S. Food and Drug Administration today announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

"AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "It is an example of how advancements in science and technology are leading to new medical care diagnostics."

AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patient's blood sample.
Specifically the test measures gene expression—or how DNA transcribes its genetic instructions to RNA, the nucleic acid that translates and carries out those instructions—of 20 different genes, resulting in a score that indicates whether a heart transplant patient is unlikely to be rejecting the new organ.

Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.

Following a heart transplant, physicians regularly monitor patients for transplant rejection, a significant risk to patient survival. Rejection occurs when the patient's immune system fails to accept the new organ and begins to attack it. Successful heart transplants depend on a balanced immune system response—a response that is suppressed enough to accept the new organ but strong enough to protect the patient from infections.

Clinicians often rely on heart biopsy to gauge whether a patient is rejecting the transplanted heart. However, biopsies are difficult to perform and can be risky for the patient.

According to the National Heart, Lung and Blood Institute, half of all possible rejections happen during the first six weeks after surgery and 25 percent of patients have signs of possible rejection at least once during the first year following a transplant.

XDx Inc. developed AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S. heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study.

According to the American Heart Association, there were more than 2,000 heart transplants performed in the United States during 2006.

AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.

Additional Information:

FDA Clears Test to Help Doctors Manage Heart Transplant Patients. FDA Press Release. August 27, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116939.htm

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HeartNet

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

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FDA Press Release

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.

The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.

Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.

Additional Information:

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures. FDA Press Release. September 4, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116941.htm

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New Device Approval - Medtronic® Attain Starfix Model 4195 Lead - P060039

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FDA has recently approved the Medtronic Attain StarFix Model 4195 lead. Using this lead in conjunction with an implanted pacing device and other leads, helps the heart chambers pump more efficiently by coordinating the timing of contractions. This improved coordination may reduce the symptoms of heart failure and is called cardiac resynchronization therapy, or CRT.

Additional Information:

New Device Approval – Medtronic Attain Starfix Model 4195 Lead – P060039. FDA. July 11, 2008.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm074045.htm

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Recently Recalled Devices

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To view recently recalled devices, please visit the website listed under Additional Information below.

Additional Information:

Recently Recalled Devices
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm

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LabNet

FDA Approves DNA Test to Measure Hepatitis B Virus Levels

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FDA Press Release

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.

“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”

HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.

Additional Information:

FDA Approves DNA Test to Measure Hepatitis B Virus Levels. FDA Press Release. September 4, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116940.htm

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ROC Curves: Uncovering the Pearls and Avoiding the Pitfalls

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By David Plaut
American Association for Clinical Chemistry (AACC)
ROC curve analysis is a set of statistical tools that helps select optimal tests and similarly helps discard suboptimal ones. The ROC curves are also helpful for selecting optimal cutoffs for a test and have become a common tool in medicine to determine the clinical accuracy of lab tests. All ROC curves are good representations of the data; it is the other factors—the lab test, the other diagnostic tests, the patients, and the clinicians—that are all imperfect.

Additional Information:

ROC Curves: Uncovering the Pearls and Avoiding the Pitfalls. By David Plaut. American Association for Clinical Chemistry (AACC). Volume 34, Number 8. August 2008.
http://www.aacc.org/publications/cln/2008/august/Pages/series_0808.aspx

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KidNet

Medical Device Problem Summaries

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Please see this month's Medical Device Problem Summary describing issues summarized from reports received by MedSun hospitals.

Additional Information:

Summary of MedSun Reports Describing Adverse Events With Infusion Pumps in Pediatric Patients and Related Articles
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=29#14

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period July 1 through July 31. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device: Airway Adapter, Pediatric, ETCO2
Lot #27110700
Catalog #8000-0361
Manufacturer: Zoll Medical Corporation (manufactured for Zoll by Respironics, Inc.)

Problem: The adapter has a clear, plastic ring that comes attached to the purple spring-like coil in the adapter. This ring separated from the coil and lodged into the trach tube causing respiratory decompensation from airway obstruction. Normal attempts to establish a patent trach were unsuccessful until the entire trach tube was emergently removed by a physician and a new one inserted. Examination of the obstructed trach tube revealed the presence of the clear ring as the cause of the obstruction. Upon examination of packaged/unopened product the clear ring easily popped off with just a slight touch.

Device: Nasopharyngeal Airway
Lot# 07E01
Other device# 123128
Manufacturer: Rusch Inc., A Division of Teleflex Medical

Problem: Nasal airway was inserted into right naris of patient for nasotracheal suctioning. While inserting suction catheter through nasal airway, the soft rubber flange of nasal airway collapsed and entire nasal airway advanced out of view into the patient's nasopharynx. Flashlight and hemostat immediately procured and used to remove nasal airway from nasopharynx. Although patient was not harmed, the potential exists for complete blockage of airway or advancement of nasal airway into esophagus.
The flange of the nasal airway is made of soft rubber and collapses easily; flaw in design of product. If just the flange were produced with a more firm rubber/plastic substance, it would not collapse so easily and have the potential of slipping into a patient's airway and blocking it, creating a respiratory emergency.

Device: CO2 absorbent; Sodasorb
Lot#CWO2-P115-21 and CWO1-P115-19
Other device #008870 and 008870
Manufacturer: Smiths Medical

Problem: While performing an atrial septal defect/ventricular septal defect repair on a 7 wk old baby, we noted ST segment elevation without changes in hemodynamics. This happened about 10 min after desflurane was initiated. We checked a CO-Ox blood gas and the carboxyhemoglobin level was 5.2% (significantly elevated). Of note, the chest was open and we looked directly at the coronary arteries and there was no evidence of any compression or perfusion abnormalities. The physician suspected that the elevated carboxyhemoglobin levels were the result of a bad batch of C02 absorbent. It has been documented in the literature that carbon monoxide is produced if volatile anesthetics (i.e. desflurane, enflurane, halothane, isoflurane and sevoflurane) come in contact with dried or desiccated CO2 absorbents, such as soda lime. Elevated carboxyhemoglobin levels in the patient can result. This particular patient’s condition stabilized after removal from the anesthesia unit. Since the CO2 absorber had been correctly changed the day prior (both canisters), we suspect that a bad batch of absorbent was received. Immediately following the incident the CO2 absorbent supplier was contacted. The canisters in question were sequestered, and were sent to an outside test lab. Areas of investigation will be lot numbers, climate control storage and the review of other hospitals with similar incidents. The anesthesia machine had undergone preventive maintenance 3 months prior, and will be tested again by Biomedical Engineering to verify correct operation.

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Monitor, Physiological
Manufacturer: Philips Medical Systems

Problem: We have reported ongoing concerns with multiple Philips G5 Intelliview Anesthetic Gas Modules in our OR's. These machines are relatively new to our facility. Our facility began using the G5 IntelliVue anesthetic gas modules (model M1019A) earlier this year. The facility immediately had problems with the G5 "locking up." The gases (desflurane, isoflurane, sevoflurane, halothane, enflurane, CO2, nitrous oxide, etc.) were displaying ???'s on the display patient monitor instead of displaying the measurement of what the gas was. This was occurring during different stages of the case, and even after the case when the pt. has been disconnected and out of the room. Philips decided to replace the original 12 machines with new ones thinking the facility received a bad batch. The facility continued to have problems. Philips sent technicians from Germany and Andover to troubleshoot issues as well as having Radio Frequency and Power experts look at possible environmental concerns. Their testing showed no obvious reasons for what was happening. The work-around that the facility uses when the problem occurs is to power down the system and/or remove the data cable from the patient monitor for 10-15 seconds and then plug back in so the data will repopulate. The problem has not affected other patient information such as the ECG and SPO2.

We have had three additional incidents reported to us, which now brings our total number of occurrences to at least 48. In communications with Philips, it has been decided to downgrade the current software in these machines to the previous version in an attempt to alleviate these issues. We have continued to troubleshoot with Philips and are hoping for a remedy shortly.

Device: Breathing Circuit, Infant
Model #: RT235
Lot #: 080326
Manufacturer: Fisher & Paykel Healthcare, Ltd.

Problem: Ventilator circuit (Fisher & Paykel RT235) patient "wye" will snap-off and cause a significant air leak with a drop in ventilator pressure.
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Manufacturer response for Ventilator Circuit, Evaqua RT235
======================
spoke with company rep and he said they are aware of the problem and would work to correct the problem. Also, would send a case of circuits.

Device: Mask, Oxygen
Manufacturer: Cardinal Health

Problem: Patient was on venturi mask set for FIO2 of 50%; mask not delivering set amount of O2 and patient sats dropped to low 80's. Flow meters discharged out, ran off a tank, and verified with an analyzer, with the white entrainment device. The highest FIO2 analyzed was 25%. The staff then placed on 31% with the blue entrainment device and the highest FIO2 analyzed was 25%. Staff tried 3 different venturi devices of the same brand with the same results. Every patient in the hospital checked to see if using this device; none found in use elsewhere. Venturi masks removed from use in entire facility, pending resolution by materials management.


CARDIOVASCULAR

Device: Defibrillator, Biphasic; M Series
Model #M Series with Xtreme Pack
Other device #CE 0197
Manufacturer: Zoll Medical Corporation

Device: Defibrillation Pad; PadPro
Model #REF 2001Z-C
Manufacturer: CONMED Corporation

Problem: During an Electrophysiology Study, sustained polymorphic ventricular tachycardia was induced x2. Cardioversion was performed on this morbidly obese patient with a Zoll defibrillator using 200 joules, biphasic. During the first episode the first of 2 shocks was ineffective at converting the rhythm. The second shock was effective. During the second episode the first and second of 3 shocks were ineffective at converting the rhythm. The third shock was effective. The energy was applied to the patient via hands free defibrillation pads. For the first event the pads were placed on the right upper chest and left apical area. The pads were replaced after the first event with new pads placed in the center of the chest, and center of the back.

Device: Defibrillator, Biphasic; M Series
Manufacturer: Zoll Medical Corporation
Problem: Patient with afibrillation (afib); history included coronary artery disease s/p stent, congestive heart failure, cardiomyopathy, hyperlipidemia. Unable to cardiovert afib using Zoll biphasic M Series device 200 joules using counter pressure. Two attempts failed to convert the patient's rhythm. Changed to a different manufacturer's 360 joule biphasic device and cardioverted to sinus rhythm with one attempt.
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Manufacturer response for Defibrillator, M Series, Biphasic
======================
They are not convinced of a problem by our interpretation of our experience.

Device: Intermittent Pneumatic Compression Device
Model #: AC600/US
Catalog #: 00679252044959
Manufacturer: Huntleigh Healthcare

Problem:
We have had 8 units at our facility fail at the connection where the hose(s) attach to the unit. When this connector pulls apart there are wires that are exposed and damaged. We are aware of at least two other facilities that are experiencing the same problem.

Device: Monitor, Physiological
Manufacturer: GE Medical Systems Information Technologies
Problem: Entire room of DASH 4000 monitors simultaneously alarmed NIBP failure. All patients checked and were fine. Monitors were all reset and problem did not reoccur. I was told that the monitors in our newly opened cardiovascular center alarmed the same failure at the same time.

Device: Monitor, Physiological
Manufacturer: GE Medical Systems Information Technologies

Problem: Mother witnessed monitor go blank and called RN. All of the RN's in room verified that CIC central station (installed as back-up alarm system) did not alarm and was also blank. Monitor was able to be restarted by shutting the power off and turning it back on again.


ORTHOPEDIC

Device: Drill, Orthopedic, Pneumatic; Black Max Drill
Manufacturer: Anspach Companies

Problem: Surgeon was using the "Black Max" drill when a loud "pop" sound was heard. The pneumatic hose attached to the drill exploded due to pressure build up in the hose. Large tear resulted in hose on distal end near drill connection. The physician was escorted to the Emergency Department for evaluation of hearing and possible ear damage. None reported. Upon review of the event, it was noted the level of oil in the Black Max foot pedal was at minimum. It was also noted that the pneumatic hose was slightly pinched under the foot of a step stool causing the pressure in the tubing to build resulting in the rupture. The hose is a double-lumen hose, and it is speculated that the exhaust section is the one with the build up and rupture. Recommend design improvement to alert to increased pressure such as alarm, pressure release value or pressure gauge.

Device: Impactor, Femoral
Model # 7401-2811
Manufacturer: Smith and Nephew

Problem: The Smith and Nephew Journey brand femoral impactor, model number: 7401-2811 has peeling and chipping issues from the black plastic coating of the CAM arms. This was brought to the attention of the OR by the manager of CSR. This issue was discussed with the sales representative and with the OR staff. Consensus was that this may be related to dried cement being chipped off. The sales rep. for this device indicated that Smith and Nephew is aware of this issue, and have had a few other cases reported. They are currently looking for a more durable product that will not chip off. The OR staff was advised of the issue/concern and will be mindful of the need to clean cement off before it hardens/dries. Smith and Nephew replaced both of the arms. Smith & Nephew, Inc.


GASTROENTEROLOGY/UROLOGY

Device: Fecal Management System; Flexi-Seal
Model# 411100
Manufacturer: Convatec, A Bristol-Myers Squibb Co.
Problem: The patient developed loose stools. A Flexi-Seal was applied to contain the stool and prevent skin breakdown. The patient became febrile and foul odor was noted, described as rotting flesh by staff. The Flexi-Seal balloon was deflated and noted to have 85 ml of fluid (the recommended amount is 45ml). Some necrotic tissue was noted on the tip, and was expelled from the patient. The patient had a rectal scope which did not show additional rectal erosion or necrosis. The Flexi-Seal had been in place for three days. Balloon over inflation could potentially lead to necrosis.


GENERAL & PLASTIC SURGERY

Device: Surgical Pack, EP, Custom
Lot #489260
Manufacturer: AVID Medical

Problem: We opened 5 EP surgery packs for a pacemaker and all 5 of them were contaminated. One with hair and 4 others with cardboard pieces.

Device: Tourniquet; Zimmer 34 inch Tourniquet Cuff, Single Port Single Bladder, Luer Lock Connector, Brown Trim
Lo t#174267
Catalog #60-7075-006
Manufacturer: Ascent Healthcare Solutions
Problem: Circulator removed surgical drapes at the end of the case and noted the thigh tourniquet on patient's right leg had "curled" up onto itself and was "hard and crunchy." No injury to the patient noted.

Note from FDA: Please see Safety Tip titled, "FDA Safety Tip: Pneumatic Tourniquet Cuffs,With a Tourniquet System" posted in January 2007's Newsletter online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11#1

Also see this month's Reporting Tip titled, "Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA"

Device: Surgical Marker
Model #: 1451
Manufacturer: Viscot Medical, LLC

Problem: A Viscot brand surgical marker was used to mark a patient's left leg for a phlebectomy in the pre-op area. Sometime after the marking procedure, the patient crossed his legs, and the marker ink was transferred to the right leg, making an exact mirror copy of the correct mark, which was on the left leg. After the patient was transferred to the operating room, the right leg (with the incorrect transferred mark) was draped and prepped. The correct surgical mark on the left leg was not detected by the staff, during the time-out procedure. However, during efforts to secure the patient's legs from thrashing, prior to the procedure, the surgical mark on the left leg was observed and procedure preparation was stopped. The correct surgical site was then verified, prepped and the procedure was preformed as planned. To prevent this issue from occurring in the future, the operating surgeon will clearly write the word 'YES' on the operative leg, which if transferred to the other leg, will result in a backwards image. A smiley face or other identifiable symbol was not selected since the mirror image would be an exact duplicate of the original, and not alert staff of an incorrect transferred mark. In addition, patients will now not be allowed to leave the preoperative area without a 'YES' mark, and staff members are also revisiting current operating room procedures, and are working with surgeons to get them more actively involved in the time-out procedure.


RADIOLOGY

Device: Gamma Camera System
Model #E-Cam
Manufacturer: Siemens Medical Solutions USA, Inc.

Problem: A series of studies were done on a particular patient. Staff were unable to locate one of the studies afterwards and it was discovered in a different patient’s file. The second patient was scanned nearly a year prior. Since staff were initially unable to locate the study, a repeat procedure was necessary. The vendor states that the technician must have selected the wrong patient, but the number of steps necessary to accomplish this, along with other details, suggest this was more likely a software error. This is particularly true since it was not a currently scheduled patient. Selecting a patient from many months prior is unlikely. The technician is convinced this was a software error and not a staff error for a number of reasons.
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Manufacturer response for Gamma Camera System
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Vendor says this was user error but our staff do not agree with that finding.

Device: X-Ray, Cardio/Vascular; Integris Allura AP
Manufacturer: Philips Medical Systems

Problem: Physician inserted 5 stents, recorded fluoroscopy time of 67.5 minutes. Discharged home two days later. Approximately two weeks after implant of stents, patient returned to Emergency Room complaining of chest pain. As planned, one month after initial implant physician inserted another stent, recorded fluoroscopy time of 107 minutes. Discharged home the next day. Nine days after second implant, patient discovered a red area on his back between the shoulder blades that looked like sunburn. It measured 3 inches by 3 inches. The area got progressively worse. The area looked more inflamed. Patient went to a dermatologist approximately 3 wks after discovery. Dermatologist examined the area and took a biopsy sample. The dermatologist said it looked like a radiation burn. Pathologist reported a differential diagnosis including a fixed drug eruption, erythema multiforma, or an autoimmune connective disease; subacute radiation dermatitis also in the differential diagnosis. Dermatologist put patient on Topicort Cream (Desoximetasone) and then Mimyx Cream.
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Manufacturer response for Cardio/Vascular X-Ray, Integris Allura AP
======================
Device was inspected by a third party. The X-Ray equipment was found to substantially comply with state and federal regulations as well as National Performance Standards established for good radiological compliance.


OPTHALAMIC

Device: Laser, Ophthalmic; VisX Excimer Laser WaveScan Software 3.9/3.901
Other Device #AMO WaveScan WaveFront Systems Software Version 3.9/3.901
Manufacturer: Advanced Medical Optics

Problem: Six patients undergoing LASIK received an over-correction due to machine software generating inappropriate treatment tables. The manufacturer has sent us an urgent device correction notice, and has provided us with upgraded software (version 3.92)

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=55273


GENERAL HOSPITAL

Device: Infusion Pump; Outlook 100
Model #13215
Manufacturer: B. Braun Medical Inc.

Problem: Our facility has previously reported ongoing issues with our new B. Braun Outlook 100 Pumps. Approximately 150 of our 700 pumps have been known to “lose” their drug libraries (i.e. the pumps default to their factory preset and prompt the user to enter the dosing information rather than allowing the user to pull information from the drug library -- this does not impact the patient as our staff can revert to manually inputting rates but it is not allowing us to utilize these pumps in the manner intended). Initially, the manufacturer provided us with software upgrades, which did not solve the problem. They have now replaced the batteries in approximately 60 of our pumps, and this seems to have resolved the issue. B Braun believes they may have gotten a bad batch of batteries from their supplier, and that it is possible these batteries ended up in our pumps. Additionally, they are working on another software enhancement to complement the new batteries, so that as the batteries age the problem of losing the drug library does not recur. B Braun has also acknowledged that two other facilities have experienced this problem.

Device: Infusion set, huber needle
Manufacturer: Bard Access Systems

Problem: Patient's mother called RN to room. Bard MiniLoc Huber Needle (female end of luer lock) broke off rest of line with needle intact. Patient was immediately re-accessed. Line flushed well with blood drawn back. Mom at bedside during procedure. MiniLoc needle examined by Clinical Engineering. Appears tubing came unglued from luer lock end. There are on-going issues with MiniLoc needles. Bard has verbally said they changed the manufacturing gluing process in April 2008, and sent us all new needles to replace old stock. Replacement began in inventory control on 5-8-08
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Manufacturer response for Safety Infusion Set, MiniLoc ======================
Bard has said they changed the manufacturing procedure in April 2008. We changed out all our lots and have not had a problem since we changed.

Device: Pump, IV, module pump, IV,CPU
Manufacturer: ALARIS Medical Systems, Inc.

Problem: Alaris infusion pump with syringe module seems to reset itself for total volume infused. Pump reports 0.19cc infused. A hour later, it was reported that 0.15cc infused without manual reset by user. Syringe started with total volume of 50cc. At time that variance noticed, volume in syringe not less than 49cc. Infusion started 3 1/2 hours prior to the variance. Pump changed, tagged, and removed from the room. Clinical Engineering evaluation: investigated keystroke logs of syringe module and PCU involved in incident. Were not able to verify the issue, however it was noted that a pressure sensing disk was used on the syringe module. Shortly after the infusion started, the syringe module log notes "disc present = true", while the PCU notes "disc present = false". The PCU should have read "true", therefore there is thought to be an unknown software or hardware issue with the PCU. Both the syringe module and PCU, as well as the LVP attached to the pump at the time will be sent to Alaris for further investigation.
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Manufacturer response for Infusion pump and syringe module, Alaris System ======================
No response yet.

Device: Pump, IV Infusion
Manufacturer: Sigma International

Problem: Patient was to receive Septra at 500ml/hr for a 1036ml bag in which there was 36ml of Septra and 1000ml of D5. The primary IV (.9NS) fluids were set to run at 125ml/hour. When the secondary IV infusion rate of 500ml/hour was supposed to have switched back to the primary rate of 125ml/hour; it didn't, and the secondary rate of 500ml continued for an amount of time unknown to the nurse. The infusion of the Septra that was mixed in the D5 took 2hrs and 45minutes to run, when it was programmed to run over 2 hours. This was due to the fast rate and subsequent running in of some of the primary fluids at the same time as the secondary fluids (Septra/D5). Between the scondary rate of 500ml/hr of running the primary fluids (.9NS)for a time, and the primary fluid (.9NS) dripping in with the Septra/D5, the patient received approximately 240-345ml of NS at the rate of 500ml/hr. Staff unsure if flow rate was set incorrectly or if something happened with the pump. This could be prevented by staff checking the patient when the secondary fluids should be finished, and also confirming the pump set up is correct. The nurse should also be sure that the primary fluid bag is hung low enough to not flow in at the same time as the secondary infustion. Clinical Engineering evaluation: A review of the event log within the pump correlated to the event information. The staff, per order attempted to infuse a secondary infusion at 500ml/hr. Operational testing of the pump in the stated configuration showed that without the primary line clamped, siphoning would occur. Current pump software does not prompt the user to monitor and clamp, if necessary, the primary line when infusing a secondary infusion above 300ml/hr. Staff to be advised to monitor any secondary infusions for siphoning of the primary bag as evidenced by primary line drip chamber activity specifically at rates nearing or above 300ml/hr.

Device: Tubing, suction irrigation; Clear ESS II RP
Device model # 0041-6153
Device lot # 805606,
Manufacturer: PhotoMedex, Inc.

Problem: The nurse reported that the Clear ESS II RP suction and irrigation tubing was stuck so it was constantly on. The physician was unable to get the device to irrigate properly. New clear ESS tubing was obtained which functioned appropriately. We have had four separate incidents of this problem, and it appears that the same lot number has been involved in three of these cases. Therefore, the lot has been removed from the shelves and the devices will be returned to the manufacturer, as they have asked us to return product for evaluation. We are in the process of getting a return authorization number so that we can return these devices to them. There has been no patient harm as a result of these failures.

Device: Thermometer
Manufacturer: Covidien (Kendall)
Problem: Several cases of inaccurate temperature have occurred: 1)Oral temperature registered 104 deg. F on a patient that had no clinical findings to support the increased temperature. Approximately 2-3 minutes later the temperature was rechecked and the unit read 98 deg. F. 2)Unit is taking 45 minutes to register on patients coming from OR. 3)Attempt to take oral temperature resulted in unit alternating between fast mode and slow mode and pointing to oral and axillary. Not successful in obtaining temperature. 4)Attempt to take oral temperature in patient with a slightly elevated temperature resulted in unit reading 95 deg. F. After several attempts the unit registered 99.5 deg. F. Biomed checked all thermometers involved for accuracy and speed. Temperature was within range and reached temp in 30 seconds.


PHYSICAL MEDICINE

Device: Heat Therapy Pack
Lot #: V8E135
Catalog #: 30104
Other #: SKU# 3014003983
Manufacturer: Cardinal Health

Problem: Staff RN was preparing an Instant Insulated Hot Pack for use on the patient. Following the package instructions the nurse squeezed the package and the package exploded through the top seal and sprayed the nurse in the face and upper body with the liquid contents of the heat pack.


OBSTETRICS/GYNECOLOGY

Device: uterine manipulator
Manufacturer: ConMed EndoScopic Technologies

Problem: V-Care manipulator broke into pieces after procedure. The entire device was accounted for post-procedure. No Patient Harm. We have had prior problems with this device, and recently received additional in-service training from the manufacturer. During the training we did not identify any procedural issues that would explain the failures.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Infusion Pumps in Pediatric Patients and Related Articles

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By Elizabeth Eydelman, Patient Safety Staff, 2008

Over the past year and a half, MedSun has received 19 adverse event reports involving infusion pump problems which occurred in the pediatric or neonatal units of each respective hospital filing the report. These reports are associated with four manufacturers: Smiths Medical (11), Baxter Healthcare Corporation (3), Abbot Laboratories, Inc. / Hospira Global Medical Affairs (3), and Alaris Medical Systems, Inc. (2). The reports were submitted by 12 hospitals between January 1st 2007 and May 12th, 2008. The most frequently reported device problems are:

• Over infusion (6)
• Incorrect programming calculations/Design or structure problem (4)
• Cessation of pumping with an error message or dislodgement of component (3)
• Under infusion (2)
• Screen won’t advance in drug library due to small patient size (1)
• Battery failure (1)
• Failure to infuse (1)
• Self-activation (1)
• Failure to alarm (1)

There are no MedSun reports involving a patient death during this time period. There are 9 reports that do not list the type of adverse event, 7 reports that list event type as malfunction, and 3 reports list the adverse event type as injury. Of the reports that list patient problems, the most frequently reported patient problems are:

• Overdose (6)
• Under dose (5)
• Need for additional therapy or surgical treatment (3)
• Skin discoloration (2)

Of the reports that list patient gender, 11 reports involve female patients and 8 reports involve male patients. These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.

An article from the American Journal of Health-System Pharmacy, posted on MedScape online 9/7/0, entitled, Using Failure Mode and Effects Analysis to Plan Implementation of Smart I.V. Pump Technology, stresses the need for multi-disciplinary communication and training so that end users consistently use the pump features and respond to dosing alerts to reprogram erroneous pump programming. A safety tip by Julia Marders, RN, MS, posted on FDA/CDRH’s Medical Device Safety Website posted 4/1/2005, Sounding the Alarm for I.V. Infiltration, advises users to make check if the IV pump is designed for pediatric or adult patients prior to use and to follow the manufacturer's recommendations for the appropriate patient population when setting the pressure for infusion and downstream occlusion to avoid infiltration.

[Note: The reports have been edited for clarity]



MedSun Infusion Pump Adverse Event Reports received between January 1st 2007 and May 12th 2008
Device Device Identifiers Event Description
Smiths Medical/Infusion Pump Model: 3500 NURSE TRYING TO INITIATE MORPHINE INFUSION ON NEW OR PATIENT. UNABLE TO ADVANCE SCREEN IN PED CARDIO/THORACIC UNIT (PCTU) DUE TO FACT PATIENT WAS LESS THAN 50KG. REFERENCED # 1 LIBRARY ANALGESICS/SEDATIVES. ALSO, WON'T ADVANCE SCREENS IN OTHER LIBRARIES. UPON FURTHER INVESTIGATION, IT WAS ALSO FOUND THAT THE BATTERIES WERE DEPLETED DUE TO OVER HEATING AND UPON TESTING EXPRESSED APPROXIMATELY 25% LESS THAN ITS ORIGINAL CAPACITY.
Smiths Medical/Infusion Pump Model: 3500 PUMP WAS PLUGGED IN AND RUNNING WITH EPINEPHRINE RUNNING AT 0.1MCG/KG/MIN (VERY HIGH DOSE TO SUPPORT BLOOD PRESSURE) WHEN IT GAVE A HIGH PITCHED TONE. THE PUMP STOPPED RUNNING. THE DISPLAY READ "1 BIOMED". THE PUMP WAS CHANGED WITHOUT INCIDENT BUT IT COULD HAVE BEEN A DISASTER.
Baxter Healthcare Corporation/Infusion Pump Model: 2M8163 DURING TRANSPORT, BAXTER THREE CHANNEL IV PUMP FAILED. PT WAS ON TWO DRIPS, MOST IMPORTANTLY, MAGNESIUM SULFATE. IV WAS CHANGED TO A SECOND PUMP AND THE REST OF THE TRIP WAS UNEVENTFUL.
Smiths Medical/Infusion Pump Model: 2001 HEPARIN INFUSION VIA PUMP. SHOULD HAVE DELIVERED 6 ML PER READING ON PUMP. SYRINGE STILL FULL AT 48.5 ML. NO VOLUME DELIVERED TO PATIENT ACCORDING TO SYRINGE LEVEL. PROBLEM IDENTIFIED BECAUSE PATIENT WAS ON ECMO AND HAVING REGULAR ACTIVATING CLOTTING TIMES DONE. CLOTTING TIME DECREASED FROM 202 TO 184 TO 155 IN 1 HOUR. PUMP SENT TO SMITHS MEDICAL FOR EVALUATION AND REPAIR. COMPANY FOUND THAT CLUTCH SPRING WAS BROKEN CAUSING THE TACK TO MOVE FREELY WITHOUT PRESSING THE CLUTCH. THIS WAS CAUSING THE PUMP TO COUNT EVEN THOUGH INFUSION WAS NOT HAPPENING.
Smiths Medical/Infusion Pump Model: 2HC07A VANCOMYCIN SYRINGE WAS PLACED ON PUMP. THE PUMP WAS PROGRAMMED TO RUN OVER A TWO HOUR PERIOD. THE NURSE WENT TO CONNECT THE LINE TO THE PATIENT AND NOTICED THAT HALF THE MEDICATION WAS ALREADY INFUSED PRIOR TO CONNECTING TO THE PATIENT. THE PUMP WAS SET AT 22 ML/HR AND THERE HAD BEEN A TOTAL OF 44 ML IN THE SYRINGE. THE PATIENT DID NOT RECEIVE ANY OF THE FIRST HALF OF THE MEDICATION. THE PUMP WAS STOPPED AND THE SYRINGE WAS REMOVED. THE PUMP WAS SENT TO THE BIOMEDICAL DEPARTMENT WHERE THEY FOUND NOTHING WRONG WITH THE PUMP.
Smiths Medical/Infusion Pump Model: 3500 MEDICATION ERROR. DECIMAL BUTTON NOT PRESSED. EQUIPMENT DOES NOT ASK FOR A CONFIRMATION. THE PUMP WAS NOT SEQUESTERED. THE EQUIPMENT'S END OF LIFE IS 2011, AND IS NOT CURRENTLY SOLD. THE PT HAD NO VISIBLE EFFECTS NOTED.
Smiths Medical/Infusion Pump Model: 2001 AT 1930 AN INFUSION PUMP ON INFANT IN NICU STOPPED INFUSING AND ALARMED "INFUSION COMPLETE." THE INFUSION WAS LIPIDS; WHICH WAS TO BE INFUSING AT 1CC/HR FOR A TOTAL OF 21 HOURS. THE INFUSION WAS STARTED AT 1800 DURING THE PRIOR SHIFT. THE PUMP ALARMED AND REPORTED THERE WAS ONLY 7CC LEFT IN THE SYRINGE, WHICH MEANT 14 CC WERE INFUSED IN 1.5 HOURS. TWO RNS EVALUATED THE SYRINGE AND VERIFIED IT ONLY CONTAINED 7CC IN IT. NO LEAKS OR WETNESS WERE NOTED SO INFUSION WAS STOPPED AND NNP (NEONATAL NURSE PRACTITIONER) WAS NOTIFIED IMMEDIATELY. THE PATIENT HAD LAB WORK DUE SO IT WAS DONE AND REVIEWED WITH NO ADVERSE OUTCOMES OR INJURY NOTED. THE NNP ORDERED NO FURTHER LIPIDS UNTIL THE NEXT DAY AND BOTH NNP AND NURSING WILL MONITOR THE INFANT CLOSELY. THE PUMP WAS REMOVED FROM SERVICE AND CLINICAL ENGINEERING WAS NOTIFIED TO PICK UP
PUMP FOR EVALUATION.
Baxter Healthcare Corporation/Infusion Pump Catalog: 1M8550 WHILE IN THE INTENSIVE CARE NURSERY THE NURSE SET THE IV PUMP FOR 1CC/HR WITH A VOLUME LIMIT SET FOR 25CC. THE SYRINGE CONTAINED 60CC OF D10W WITH CALCIUM GLUCONATE. THE FLUIDS WERE STARTED AT 15:30. AT 16:00 THE SYRINGE PUMP WAS ALARMING INFUSION COMPLETE. WHEN NURSE CHECKED THE SYRINGE THERE WAS 0CC LEFT IN THE SYRINGE. THE IV PUMP SETTING WAS CHECKED WITH A SECOND NURSE. THE IV PUMP WAS SET CORRECTLY AT 1CC/HR WITH A VOLUME LIMIT OF 25CC. THE PUMP WAS READING 60CC INFUSED OVER 30 MINUTES. PUMP REMOVED FROM THE UNIT.
Smiths Medical/Infusion Pump Model: 3500 THE PATIENT WAS AN ACTIVE TODDLER RECEIVING MILRINONE AT A RATE OF 0.5 MCG/KG. THE PATIENT'S MOM LEFT THE ROOM, THE NURSE WENT TO CHECK ON THE PATIENT AND FOUND THAT THE SYRINGE OF MILRINONE HAD BEEN REMOVED FROM THE PUMP BY THE PATIENT AND WAS IN HIS HAND. THE NURSE VERIFIED AND CONFIRMED THAT NO EXTRA MEDICATION HAD BEEN DELIVERED. THIS PUMP DOES NOT LOCK, INSTEAD THE SYRINGE IS CLAMPED INTO THE PUMP. TO AVOID THIS FROM HAPPENING AGAIN, IT WOULD BE HELPFUL IF THERE WAS A LOCKING DEVICE ATTACHMENT AVAILABLE THAT COULD BE AFFIXED TO THE PUMPS FOR USE IN THE PEDIATRIC POPULATION.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/Infusion Pump Model: 12391-04-04 NURSE PROGRAMMED INFUSION PUMP AT 21 ML/HOUR INSTEAD OF 6.9 ML
Alaris Medical Systems, Inc./Infusion Pump Model: 8015, 8100 A NEW IV HAD BEEN STARTED AT 1900 HOURS ON THE LEFT ARM. THE ARM WAS CHECKED BY STAFF AT 2000, 2100, AND 2200 HOURS WITH THE SITE BEING NOTED AS CLEAR. AT THE 2300 HOURS THERE WAS A DISCOLORATION UNDER THE TAPE ON THE LEFT ARM WHICH RESULTED IN FOUR MARKS. THE IV WAS DISCONTINUED AND THE PUMP REMOVED FROM THE PATIENT AND BIOMED NOTIFIED. PHARMACY WAS ALSO CALLED TO CHECK ON THE CALCULATIONS AND SOLUTION AND VERIFIED THAT IT WAS ACCURATE. THE PUMP HAD DELIVERED IN 12 HOURS, WHAT SHOULD HAVE TAKEN 24 HOURS. THE PUMP WITH MODULES WERE SENT TO THE MANUFACTURER FOR ANALYSIS AND THE FACILITY IS WAITING FOR A RESPONSE.
Alaris Medical Systems, Inc./Infusion Pumps Model: 8015, 8100 THE BAG OF TPN WAS CHECKED AND ONLY 2.5 HOURS WERE LEFT TO DELIVER. THE BAG OF TPN SHOULD HAVE LASTED FOR 24 HOURS. BIOMED WAS NOTIFIED AND SECURED THE PUMP. PHARMACY WAS ALSO NOTIFIED TO REVIEW THE TPN CALCULATIONS AND CONFIRMED THE SOLUTION WAS ACCURATE. THE PUMP WITH MODULES WERE SENT TO THE MANUFACTURER FOR EVALUATION AND ARE AWAITING AN OFFICIAL RESPONSE.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/ Infusion Pump Device Identifiers Unknown/Not Available WHILE USING AN ABBOTT PLUM A PUMP, THE IV WAS FOUND TO BE INFILTRATED WITH BLISTER FLUID DURING THE ASSESSMENT. THE IV SITE WAS VERY SWOLLEN AND THE TOP OF THE FOOT WAS BLANCHED AND MEASURED 10CM AROUND THE FOOT. THE SECURITY BAND WAS ALSO ON THIS FOOT AND WAS FOUND TO BE VERY TIGHT ABOVE AND BELOW THE BAND. THE IV AND THE SECURITY BAND WERE REMOVED, AND THE FOOT WAS ELEVATED. A PLASTIC SURGERY CONSULTATION WAS CONDUCTED TWO WEEKS LATER, WHICH REVEALED THAT AFTER THE SCAB FALLS OFF, THERE SHOULD BE NO RESIDUAL EFFECTS DUE TO THE INFILTRATION. NO ALARMS SOUNDED DURING THIS EVENT.
Baxter Healthcare Corporation/Infusion Pump Model AS50 PROSTAGLANDINS INFUSING VIA BAXTER PUMP. PUMP STOPPED, WHEN RN WENT TO RESTART PUMP, GREEN START KEY WAS DISLODGED.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/Infusion Pump Model: 5000 NOTED THAT 30 CC OF LIPIDS SYRINGE WAS EMPTY. RATE ON INFUSION PUMP CHECKED AND WAS CORRECT. CHARGE NURSE NOTIFIED, AND WAS DETERMINED TO ORDER ANOTHER 30 CC SYRINGE FROM PHARMACY AND CONNECT TO INFUSION PUMP. INFUSING AT ORDERED RATE OF 0.7 CC/HR. APPROXIMATELY 5 HOURS LATER, SECOND SYRINGE OF LIPIDS WAS FOUND TO BE INFUSED. THE PHYSICIAN WAS NOTIFIED. PUMP AND TUBING REMOVED AND KEPT FOR INSPECTION. THE TPN AND THE LIPID INFUSION RATE HAD BEEN CROSSED. THE LIPIDS WERE RUNNING AT THE FASTER RATE AND THE BABY RECEIVED TOO MUCH LIPIDS. LABS DRAWN AND X-RAYS WERE TAKEN. BABY ON VENTILATOR -SETTINGS ARE 15/4, RATE OF 60, 40-60 FIXED OX. SETTINGS REMAIN UNCHANGED FROM EARLIER IN THE DAY. PHYSICIAN NOTIFIED OF LAB RESULTS. BLOOD ORDERED FOR EXCHANGE TRANSFUSION. OUR IV TUBING (#11374 50 ML BURETTE) HAD BEEN PLACED ON BACKORDER BY HOSPIRA AND WE WERE USING A SUBSTITUTE THAT HAD INSTRUCTIONS POSTED ON HOW TO PUT IT TOGETHER. THERE WAS NOT ANY AVAILABLE TUBING EXACTLY LIKE THE ONE WE USUALLY USE. THE HOSPIRA REP HAD BEEN INTO THE UNIT DAILY TO SEE IF THE BACK UP SYSTEM WAS WORKING AND IF WE NEEDED TO CHANGE THINGS. WE WERE HAVING DIFFICULTY USING A 3-PIECE SYSTEM BECAUSE THE STAFF WAS HAVING PROBLEMS GETTING ALL OF THE AIR OUT OF THE LINE. BABY HAD NOT EXPERIENCED ANY LASTING COMPLICATIONS AT THIS POINT AND IS CONTINUED TO BE MONITORED.
Smiths Medical/Infusion Pumps Model: 3500 SYRINGE INFUSION PUMP STOPPED AND BEEPED "CHECK CLUTCH." SYRINGE PUMP TAGGED WITH INFO AND PLACED IN SOILED ROOM. NEW SYRINGE PUMP USED.
Smiths Medical/Infusion Pump Model: Medfusion 2001 PATIENT'S CONDITION INDICATED THAT THERE WAS A POSSIBLE UNDERINFUSION OF MEDICATION. DEVICE ALARMED SYSTEM ERROR. WHEN INSPECTED, SOME DAMAGE WAS NOTED. THE DEVICE HAD A LOOSE PLUNGER TRACK AND THERE WERE CRACKS AROUND THE SCREW HOLES OF THE SLIDE HOUSING CAUSING UNDERINFUSION.
Smiths Medical/Infusion Pump Model: 2010 POSSIBLE UNDERINFUSION OF IV MEDICATION INDICATED BY PATIENT RESPONSE TO DRUG BEING INFUSED. INFUSION PUMP WAS PROGRAMMED TO DELIVER BODY WEIGHT/CONCENTRATION MODE WHICH IS USED BY ANESTHESIA. NURSING USES VOLUME OVER TIME AND RATE MODE, CAUSING CONFUSION TO NURSE OPERATOR AND POSSIBLY INDUCED PROGRAMMING ERROR.
Smiths Medical/Infusion Pump Model: 2010 UNDER INFUSION OF MEDICATION. THE PUMP HAD ALARMED FOR THE "CHECK CLUTCH" SENSOR. PUMP WAS RESET AND THE SYRINGE MARKED FOR VOLUME MEASUREMENT. TWO HOURS LATER, ANOTHER "CHECK CLUTCH" ALARM WAS NOTED AND NO VOLUME HAD INFUSED SINCE THE LAST ALARM.

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Updated October 1, 2008

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