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U.S. Department of Health and Human Services

MedSun: Newsletter #96, June 2014

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Newsletter #96, June 2014

Discussions with Healthcare Providers

Clinical Electronic Thermometers: Small Sample Survey Summary

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Survey Topic: Clinical Electronic Thermometers - Survey Final Report
Year Conducted: 2014


Introduction

Clinical electronic thermometers are medical devices used to measure body temperature of patients by means of a transducer coupled with an electronic signal amplification, conditioning and display unit. Assessing an individual’s body temperature is one of the vital signs performed by health care providers to evaluate a patient’s general health. Electronic thermometers may be used in a variety of settings that include hospitals, other health care environments and the home. There are many types of electronic thermometers available due to recent advances in thermometer design including digital, electronic direct and predictive, infra-red ear and skin thermometers, and dot-matrix or phase change thermometers. Thermometers may also be a component of other medical devices used in the clinical setting such as physiologic monitors, esophageal probes, ventilators, and urinary catheters.

The FDA conducted a small sample survey to speak with clinicians and biomedical engineers to learn about users’ experiences with these devices in the hospital setting. The survey questions focused specifically on clinical electronic thermometers that are stand-alone or separate devices and are not a component of another medical device, such as a physiologic monitor or urinary catheter. Information from the survey is intended to help FDA obtain a better understanding about these devices from users to identify potential areas of improvement in performance and reliability.

Methodology

A small sample of health care providers from hospitals that participate in FDA’s Medical Product Safety Network (MedSun) were queried to obtain detailed and in-depth perspectives about the use of clinical electronic thermometers. Respondents from 14 different hospitals (located in the West, Midwest, Northeast, and Southern regions of the U.S.) participated in the voluntary survey.

Five hospitals that participated in the survey have over 500 beds. Seven hospitals have over 100 beds and two hospitals have less than 100 beds. Three institutions are children’s hospitals. All selected respondents have experience with clinical electronic thermometers and represent various clinical areas in the hospital environment.

The respondent sample included health care providers representing several areas of a hospital, such as Risk Management/Legal, Clinical Education, Nurse Management, Procurement, Safety and Patient Satisfaction, and Biomedical and Clinical Engineering. The respondents who were clinicians represent specialty areas such as neonatal intensive care, labor and delivery, pediatrics, medical/surgical, critical care, neurology critical care, telemetry, and post-anesthesia care.

Overview of Responses
General:

The hospitals in the survey use many types and models of electronic thermometers from various different manufacturers. Some hospitals have models and types of these devices from as few as two manufacturers to eight different manufacturers. Most respondents’ hospitals use electronic thermometers that measure oral, rectal and axillary temperatures as their primary device. Some hospitals use temporal artery thermometers as their primary device; a few hospitals also use tympanic thermometers primarily in certain specialty areas. All respondents say that digital and dot matrix thermometers are used most often for patients in isolation rooms and are thrown away when the patient leaves the unit. Two respondents report that their hospitals have attempted to standardize the type and brand of thermometer used in all clinical areas to increase staff familiarity, promote consistency with device use, and mitigate problems related to healthcare provider technique.

Numbers per Unit

The majority of the hospitals surveyed have thermometer units in each patient room that are mounted on the wall but may also have other types of thermometer devices available for use, such as one that is incorporated in a physiologic monitor or vital sign machine. For hospitals that share thermometers among several patients in multiple rooms, the number of electronic thermometers available per nursing unit ranges from three to eight and depends on unit size. Back up devices of the same model and type are usually available in several places such as the nursing station, the biomedical department or in an equipment storage area. However, respondents say that when thermometers are located in individual patient rooms there is less need for additional devices and it eliminates the need for staff to search for one.

Preferred Models

The types and models used by different clinical specialties vary among hospitals except for areas such as pre-operative and post-operative units where temporal artery thermometers are mostly used. Staff in these areas believes it’s critical to measure the patient’s core temperature and add that it may be difficult to access a patient’s mouth particularly after surgery.

According to some respondents, additional reasons for staff preference for the temporal artery thermometer model are that it’s quick, there’s less operator variability with technique (compared to the tympanic model), and the newer technology seems very accurate. One respondent whose hospital uses only one manufacturer’s brand of digital thermometers says it takes more time to obtain a reading from it than other manufacturers’ digital thermometers. Another respondent from a pediatric hospital believes the temporal model is easier to use with children. However, one respondent’s hospital decided not to use the temporal model after searching the literature and finding that proper technique may be an issue with accuracy. In this situation, the hospital determined that the effort required for staff training in their large facility to ensure accurate readings would not be cost-effective.

Several respondents believe staff prefers not to use the tympanic thermometer for two main reasons. Both the amount of skill required for proper positioning towards the tympanic membrane and the tendency for the device probe to get dirty from earwax affect the accuracy of temperature readings.

In general, respondents mention that thermometers with a memory feature or recall button for accessing the previous temperature measurement is very helpful and they use it often.

Common Problems and Repairs

The most common problems or repairs needed with various types of electronic thermometers as reported by one or more respondents are shown in Table 1. Many believe that knowing and using the proper technique is important to obtaining an accurate temperature reading. Patient movement, particularly in a pediatric setting, can affect the ability to get an accurate and consistent temperature. Additionally, respondents say that if a patient is diaphoretic (perspiring) it may be best to choose an alternate method since moisture may affect the accuracy of temporal artery thermometers.

Table 1. Most Common Problems and Repairs by Type of Thermometer as Reported By One or More Respondents

Digital Oral/Rectal AxillaryDisposable, Digital Oral/Rectal/AxillaryTemporal ArteryTympanicDot Matrix
Incorrect technique affects reading.Readings can be 0.6-1.2 degrees higher than other manufacturer models.Incorrect technique affects reading.Incorrect technique affects reading.Staff question accuracy.
Patient movement affects reading.Readings take a long time to display.Patient perspiration affects reading.Patient movement affects reading.
It’s difficult to use an oral probe with oncology patients who have mouth sores.Battery depletion occurs.Physical damage occurs from being dropped.Difficulties with calibrations may occur due to sensitivity to light, air current, and humidity.
Physical damage occurs from being dropped. Battery depletion occurs.Lenses, tips, and tip covers crack; tips get dirty;
Battery depletion occurs. Physical damage occurs from being dropped.
Devices are misplaced. Battery depletion occurs.
Devices are stolen. Devices are stolen.
Probe tips and cables break.


One respondent from a children’s hospital expresses concern over the difference in measurements between a disposable, digital model and other manufacturers’ non-disposable digital models they use. To address this concern with this particular model, the hospital conducted testing and noted that the disposable, digital thermometer readings can be between 0.6 to 1.2 degrees higher than the digital readings from other manufacturers’ non-disposable thermometers. Additionally, the disposable model was taking a longer time to display readings than expected.

Although most respondents think thermometers that measure an oral, rectal or axillary temperature are mostly reliable, common problems exist such as breakage of probe tips and probe cables. There are also problems with the physical case, often due to wear and tear, but respondents add that device misuse by staff is common. Physical damage that occurs from devices being dropped is also a problem with the temporal artery and tympanic thermometers.

Four respondents who are biomedical engineers report a problem with the testing/calibration equipment for a tympanic thermometer they use in their hospitals. They observe sensitivities to air flow, light and possibly humidity when trying to calibrate the device using the manufacturer’s calibration equipment. Other issues with the tympanic model include cracked lenses and tips that may be due to improper cleaning and use of an excess amount of alcohol for cleaning.

Reliability and Inaccurate Readings

All of the respondents say that when nursing staff obtain a temperature measurement that appears inaccurate they will usually check it again using a different thermometer. If the question of accuracy continues, some staff will attempt to troubleshoot the device. If the inaccurate measurement persists, staff will typically contact their biomedical engineer and try a different temperature method. Respondents say in areas such as the neonatal intensive care unit (NICU), thermoregulation of patients is particularly important so staff will make every effort to assure they are able to get accurate readings from patients.

When asked if respondents’ hospitals have a policy for managing inaccurate thermometer readings, most say there is none, but add that staff will typically follow their nursing protocol.

Importance of Thermometers to Clinical Operations

All respondents report that thermometers are critical to their clinical operations and provide examples of areas such as the post anesthesia care unit (PACU) and oncology units where a patient’s core temperature reading is critical. Also, temperature measurement is a key indicator for patients in the NICU who need assistance with thermoregulation and may require a cooling or warming device. Respondents say that many clinical decisions are based on thermometer readings particularly for patients who are critically ill, but add that other factors are included in the medical assessment such as labs, blood pressure and other vital signs. When asked to compare the importance of temperature with blood pressure readings, most respondents believe that temperature measurements are just as critical, particularly in the pediatric population, and emphasize the importance of the individual patient’s total clinical picture.

Other Areas of the Hospital Where Temperature Measurement Is Important

In addition to the NICU, the pre-operative area, the PACU, and other intensive care units, respondents specify other clinical areas of the hospital where temperature measurement may also be important. These areas include:

• Transplant Units;
• Emergency Room (uses temperature as one of the metrics to evaluate patients and whether it’s appropriate or not to treat them);
• Neurology;
• Renal;
• Orthopedics;
• Cardiology;
• Pediatric Intensive Care Unit (PICU);
• Same day surgery;
• Endoscopy Unit;
• Burn Unit;
• Operating Room (OR);
• Labor and Delivery (L&D); and,
• Oncology Unit.

In response to a question about temperature practices related to oncology and NICU patients, a respondent in one hospital reports there are no specific recommendations made by staff about specific thermometer types or brands to use at home. At the time of discharge in this particular hospital, patients are given the digital oral thermometer they used as an in-patient. The respondent adds that according to an oncology educator, for patients who did not use an oral thermometer, a tympanic model is suggested rather than a temporal one. For NICU patients, there is also no specific recommendation made about the brand or type of thermometer for home use. Some family members are instructed to take an axillary temperature using a digital thermometer and if the reading is not within the normal range, they should take a rectal temperature. Concurrently, if the rectal temperature reading is not within the normal range, they are told to notify their individual health care provider.

Experience with Other Types of Thermometers and Accuracy

When asked about the accuracy of other types of thermometers, most respondents have no experience with pacifier thermometer models and few are familiar with thermometer strips. Some respondents remember these particular models as inaccurate and possibly affected by the physical environment. The respondents who are clinicians believe that technique is critical and it’s important for the device user to know if the type of thermometer is measuring the patient’s core temperature or if the measurement is a “predicted” measure and to be able to make the adjustment for the reading.

When asked about reliability, respondents consider their clinical electronic thermometers to be reliable, but add that they think the newer products seem more dependable.

Budgetary Designation

All of the respondents express difficulty with knowing how much of the budget is designated for clinical thermometers. Most say they are often purchased in a large amount at one time particularly when new units are opened or a general change is made in the manufacturer brand for the hospital. In terms of cost, many biomedical engineers have the ability to replace a thermometer when necessary if it is under a certain dollar amount. Respondents say that replacements are usually a direct exchange with the manufacturer. They add that costs per unit vary but can range from $125.00 to $500.00 depending on the particular device. One biomedical engineer reports that if a nursing unit has a clinical electronic thermometer that has been dropped and damaged, it’s replaced using money from the individual unit budget.

Staff Training

Training about thermometer use at all of the respondents’ hospitals occurs during the orientation period for new employees. If needed, additional one-to-one training is provided to staff. Clinical educators are also available at some hospitals for validation of training on nursing units.

Instructions for Use

All respondents believe that the instructions for use of clinical electronic thermometers are easy to follow and self-explanatory. Sometimes instructions are made available to staff on the nursing unit.

Manufacturer Recalls

When asked what action would be taken if a recall occurred involving their current devices, all respondents say they would follow their hospital’s protocol for managing recalls. Respondents add that it would depend on the type of recall, but most would find replacements as quickly as possible and conduct the necessary training for staff. However, all respondents say that a recall would have a big impact and cause a shortage of devices in their facilities. Additionally, it would affect their work flow particularly if staff needed to share replacement devices. Some hospitals have over a thousand clinical electronic thermometers currently in service that could be affected if this type of situation occurred.

Preventive Maintenance

Most respondents say they track their electronic thermometers, but do not have them on a Preventive Maintenance schedule. Some will check thermometers along with other devices that are due for routine testing on a nursing unit. When thermometers are brought to biomedical/clinical engineering for repair, all respondents report that testing “after repair” is always conducted.

Battery Replacements

Batteries are most often replaced by clinical engineering, but staff can also replace them on some nursing units. Thermometers that are mounted on walls in individual patient rooms require service by the biomedical or clinical engineer. None of the respondents report having problems such as leakage or corrosion of the batteries used in thermometers.

Additional information About Clinical Electronic Thermometers

Respondents provide the following additional information about clinical electronic thermometers.

• More improvements in technology are needed to decrease operator variability with technique.
• Automatic self-checks prior to use will help ensure all electronics are operating accurately.
• More descriptive error messages on temporal artery thermometers would help instruct staff when the device isn’t being used correctly and to change technique before retaking the temperature.
• Smaller temporal artery thermometers would be helpful.
• Temporal artery thermometers that can be used under low light circumstances would be helpful.
• The large size of the temporal artery thermometers is a good safety feature.
• It’s important to teach staff about the differences with temperature readings, particularly with devices that measure a patient’s core temperature.
• A message on the tympanic thermometer would be helpful to let the user know if the device is aimed correctly or incorrectly at the tympanic membrane.
• RFIDs incorporated in thermometers by manufacturers would help improve facility tracking of the devices.
• At least one flat surface (instead of a curved surface) on thermometers would provide proper biomedical tagging for a facility control number or preventive maintenance due date.
• Non-contact battery charging units that recharge after each use would help to decrease the number of biomedical hours used for replacing batteries.
• More security features or options on thermometers would help to prevent theft.
• Stronger battery cases would help to prevent damage if the device is dropped.
• Thermometers models that can record temperatures below 92.3 degrees Fahrenheit would help when infants are admitted to hospitals with a low birth weight and need assistance with thermoregulation.
• A device warranty on temperature probes that is longer than 90 days would be helpful.

Summary

In general, respondents think that clinical electronic thermometers are reliable. Respondents say they are easy to use, but most say that with some types of thermometers, technique is more of an issue and can affect readings. All respondents consider these devices to be critical to their clinical operations and emphasize that accurate temperature measurements are particularly important in areas such as the PACU, NICU, and oncology units, but add that temperature readings are essential in other areas where patients are critically ill. Temperature measurements provide additional information about a patient’s condition that respondents believe is essential to understanding the total clinical picture.

There are various types and manufacturer models used among respondents’ hospitals with some having as few as two manufacturer models in service to as many as eight different manufacturer models of thermometers in one facility. A few respondents’ hospitals are currently attempting to standardize the type and brand they use to increase staff familiarity and consistency with device use, and to help mitigate problems related to user technique.

Most of the problems reported by one or more respondents with several types of thermometers involve incorrect user technique, breakage of probe tips and cables, physical damage due to wear and tear, and damage to devices from being dropped. Insufficient battery power is also a common problem with thermometers. All respondents believe that if the thermometers used in their hospital were involved in a recall, it would present a device shortage and have an impact on their staff work flow and clinical operations.

Survey Limitations

Although the findings add to FDA’s knowledge of clinical and engineering experiences, and provide perspectives about the use of the clinical electronic thermometers, there are several limitations to the survey methodology. The small sample size of the survey limits the findings, the respondents represent only the acute care setting, and not all clinical areas in a hospital where clinical electronic thermometers are used were involved in the survey. Also, due to the limited number of respondents and great variability among device types and models used in respondents’ hospitals, additional information and clarification about why certain devices may or may not be used may provide more findings. In view of these limitations, the respondents’ perspectives may not represent the perspectives of all device users.

Therefore, these findings represent only one piece of information. No conclusions can be made about how the device functions in the broader clinical environment based on this report alone. Instead, the report should be considered along with other information that may include adverse event reports, scientific publications, enforcement/compliance information, and other data sources that are part of FDA’s monitoring of device performance.

Surveying device users is one of many tools the FDA uses to evaluate the public health impact of potential problems associated with the use of medical devices. Typically, small sample surveys are used to collect qualitative information on post-market experiences of clinicians or facilities with medical device performance or use. The FDA selects survey respondents based on their experience with the topic or device, their availability, and their willingness to participate.

The FDA makes our scientific, medical, nursing, and engineering staff aware of the survey results as needed. If the FDA believes there is a significant risk of adverse events as noted from the survey, we will combine those results with data gained from other sources. The FDA will work with the manufacturers and health care provider organizations to make important information known to the clinical community. Additionally, the FDA continues to work with manufacturers to ensure the development, testing, and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, the FDA may convene a group of clinical, scientific, and regulatory experts to discuss any necessary actions.

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Articles

Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication

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FDA MedWatch Safety Alert

ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line. ASP is able to ship only 30 percent of its normal capacity for the Sterrad Cyclesure 24 Biological Indicator. ASP expects to increase production by July 2014 and anticipates being able to meet the full product demand by August 2014. Use an alternative low-temperature sterilizer, if available. When possible, prioritize using Sterrad Cyclesure 24 Biological Indicators for sterilization loads that contain the most critical instruments for the most urgent patient cases.

Additional Information:

Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication. FDA MedWatch Safety Alert. May 23, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398731.htm

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Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall

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FDA MedWatch Safety Alert

Fisher & Paykel Healthcare received 24 reports in which the affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction. The use of the affected product may cause serious adverse health consequences. Starting April 11, 2014, Fisher & Paykel Healthcare sent its customers an Urgent Medical Device Recall letter. The letter identified the product, problem, and actions to be taken.

Additional Information:

Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall. FDA MedWatch Safety Alert. May 23, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398670.htm

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Baxter ABACUS TPN Calculation Software: Class I Recall

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FDA MedWatch Safety Alert

Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. Symptoms may be non-specific and include nausea, vomiting, dizziness or fatigue. Some more severe symptoms include a problem with the rate or rhythm of the heartbeat (cardiac arrhythmia), an abnormal buildup of fluid in the air sacs of the lungs, which leads to shortness of breath (pulmonary edema), congestive heart failure and seizures. The affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014. On April 21, 2014, Baxter sent an Urgent Device Correction letter to all affected customers. Baxter’s letter directed customers to contact Baxter to ensure that the ABACUS software is configured correctly. Customers with a software version earlier than 3.1 will have software version 3.1 installed that addresses the issues in the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.

Additional Information:

Baxter ABACUS TPN Calculation Software: Class I Recall. FDA MedWatch Safety Alert. May 22, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398509.htm

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Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall

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FDA MedWatch Safety Alert

FDA notified health professionals of a Class I Recall due to a fan assembly for the affected Intra-Aortic Balloon Pumps (IABP) that could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning. This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs.

Additional Information:

Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall. FDA MedWatch Safety Alert. May 22, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396903.htm

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Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall

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FDA MedWatch Safety Alert

CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the “Delay For” Option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. The firm recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. CareFusion will contact all affected customers to schedule the installation of software version 9.1.17. Do NOT use the Alaris Pump module “Delay Until” option. Do NOT use the “Multidose” feature. As an interim guidance, customers may update their dataset to disable both Delay Options and/or Multidose across all Profiles to prevent the use of “Delay Until” option and/or “Multidose” feature. These are shared configurations with the Alaris Syringe module and if disabled would prevent use of these features with the Alaris Syringe module as well.

Additional Information:

Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall. FDA MedWatch Safety Alert. May 21, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htm

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Ventlab Resuscitator Bags: Recall

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FDA MedWatch Safety Alert

Ventlab, LLC. initiated a voluntary medical device removal of certain Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation. Users who have resuscitation bags within the lot numbers listed in the firm's press release should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products. Ventlab, LLC. will notify its distributors and customers by a direct mailing and arrange for the return and replacement of all of the recalled resuscitation bags.

Additional Information:

Ventlab Resuscitator Bags: Recall. FDA MedWatch Safety Alert. May 16, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397749.htm

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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 May 2014. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device
Type: Battery Pack
Manufacturer: KLS Martin LP
Brand: Kls Martin
Lot #: 32616592
Cat #: 50-800-02-91
Other #: 50-800-02-04

Problem
After the patient had left the room the trash was noted to be smoking and quickly caught fire. There were two nurses in the operating room at the time. They first dumped fluids on the fire but it was not extinguished. The fire alarm was pulled, then the fire was extinguished using a fire extinguisher. The fire department responded and verified the fire was completely out. The source of ignition appears to be a discarded battery pack from the drill. The contacts of the battery apparently shorted out on pieces of aluminum foil or wire that were in the trash bag, overheated, and caught on fire. Numerous foil packages from sutures and scalpel blades were observed in the trash and they are highly conductive on the surface.
Directions for Use that come with the battery include a warning against shorting the terminals and to dispose of the battery properly. The terminals on the battery protrude from the case and are relatively easy to short out. Recessed terminals would be less likely to short.
There was NO patient involvement as the patient had already left the room and the damage was confined to the trash bag.

======================
Manufacturer response for Battery Pack, KLS Martin (per site reporter)
======================
Awaiting evaluation of device.

Device
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc
Brand: L-cath Picc S/l
Lot #: 11052853
Cat #: 384061
Other #: L-Cath Kit: PICC lot # 11053852

Problem
We are seeing problems with the L-Cath PICC Kit. Placing a Peripherally inserted central catheter (PICC) on a neonate. The introducer needle was inserted with ease, blood obtained and catheter inserted with ease. Splittable needle withdrawn and when snapping wings of needle, one wing broke off leaving needle and remaining wing around PICC. Additional instruments needed to remove remaining needle and wing. Fortunately the catheter was not damaged in the process and there were no inadvertent needle sticks when the needle was attempted to be peeled away to be able to save the line. The PICC was then advanced and placed successfully. This infant had very limited IV access and this incident could have resulted in extra needle sticks to establish a line. This facility has had similar events on other patients with this product. Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line. In the last few months, more than four similar events have occurred. The manufacturer has been notified and product has been returned to them for testing.

Device
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc
Brand: L-cath Picc S/l
Cat #: 384061

Problem
We are seeing problems with the L-Cath PICC Kit. Placing a Peripherally inserted central catheter (PICC) on a neonate. The introducer needle was inserted with ease, blood obtained and catheter inserted with ease. Splittable needle withdrawn and when snapping wings of needle, one wing broke off leaving needle and remaining wing around PICC. Additional instruments needed to remove remaining needle and wing. Fortunately the catheter was not damaged in the process and there were no inadvertent needle sticks when the needle was attempted to be peeled away to be able to save the line. The PICC was then advanced and placed successfully. This infant had very limited IV access and this incident could have resulted in extra needle sticks to establish a line. This facility has had similar events on other patients with this product. Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line. In the last few months, more than four similar events have occurred. The manufacturer has been notified and product has been returned to them for testing.

Device
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc
Brand: L-cath Picc S/l
Cat #: 384061

Problem
We are seeing problems with the L-Cath PICC Kit. Placing a Peripherally inserted central catheter (PICC) on a neonate. The introducer needle was inserted with ease, blood obtained and catheter inserted with ease. Splittable needle withdrawn and when snapping wings of needle, one wing broke off leaving needle and remaining wing around PICC. Additional instruments needed to remove remaining needle and wing. Fortunately the catheter was not damaged in the process and there were no inadvertent needle sticks when the needle was attempted to be peeled away to be able to save the line. The PICC was then advanced and placed successfully. This infant had very limited IV access and this incident could have resulted in extra needle sticks to establish a line. This facility has had similar events on other patients with this product. Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line. In the last few months, more than four similar events have occurred. The manufacturer has been notified and product has been returned to them for testing.


Device
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc
Brand: L-cath Picc S/l
Cat #: 384061

Problem
We are seeing problems with the L-Cath PICC Kit. Placing a Peripherally inserted central catheter (PICC) on a neonate. The introducer needle was inserted with ease, blood obtained and catheter inserted with ease. Splittable needle withdrawn and when snapping wings of needle, one wing broke off leaving needle and remaining wing around PICC. Additional instruments needed to remove remaining needle and wing. Fortunately the catheter was not damaged in the process and there were no inadvertent needle sticks when the needle was attempted to be peeled away to be able to save the line. The PICC was then advanced and placed successfully. This infant had very limited IV access and this incident could have resulted in extra needle sticks to establish a line. This facility has had similar events on other patients with this product. Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line. In the last few months, more than four similar events have occurred. The manufacturer has been notified and product has been returned to them for testing.


Device
Type: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: Smith's Medical ASD
Brand: Protectiv Plus-w Radiopaque Ocrilon Polyurethane Iv Catheter Winged Hub
Lot #: esi66415
Cat #: 3087
Other #: 20G x 1"

Problem
Patient was in the ED and was ready for discharge. IV angio cath broke when being discontinued, tip of catheter retained in patient. IV was in place for less than 24 hours. Routine removal of IV for discharge from ED. RN encountered resistance while removing IV. When removed, noted part was missing. Additional medical intervention required. MD notified, patient admitted, & consult to vascular surgery placed. Pt admitted for evaluation of foreign body--went to OR and foreign body was removed successfully. Tolerated procedure well. Pt has since been discharged to home. No difficulty with IV insertion. Staff involved in the event are experienced with this equipment and have not had this type of problem in the past. Manufacturer rep notified of event.


Device
Type: Electrode, Ph, Stomach
Manufacturer: Given Imaging
Brand: Bravo Ph
Model#: BR-0000749

Problem
Outpatient procedure for a 96 hr Bravo PH study using a Bravo monitor: the patient returned 5 days later as indicated. When the device was uploaded, only 6 hrs of the 96 hr study were found recorded. The device was sent to the manufacturer in an attempt to extract the additional recording, but was not successful. Patient was not injured, but was required to undergo a subsequent procedure as a result of the device malfunction. This is the third such report of this device malfunctioning at this facility. In the previous instances, the data was recovered by the manufacturer's engineers.

Device
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: DeRoyal Industries, Inc.
Brand: Extendevac
Lot #: 34989144
Cat #: 88-000722

Problem
The Electrosurgical Generator activated without user pressing the activation button on the pencil.
Our observation is that fluid (blood) may be entering into the pencil at a very small gap in the union of two pieces of the handpiece. We can see a small bubble produced at this location when pressing on one of the buttons. There appears to be fluid internal at this location. I will e-mail you a picture showing this location. We have contacted the vendor to let them know. The response was no one else had this problem.

Device
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: DeRoyal Industries, Inc.
Brand: Extendevac
Lot #: 35076152
Cat #: 88-000722

Problem
The Electrosurgical Generator activated without user pressing the activation button on the pencil.
Our observation is that fluid (blood) may be entering into the pencil at a very small gap in the union of two pieces of the handpiece. We can see a small bubble produced at this location when pressing on one of the buttons. There appears to be fluid internal at this location. I will e-mail you a picture showing this location. We have contacted the vendor to let them know. The response was no one else had this problem.


Device
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: Covidien formerly Valleylab
Brand: Force 2
Model#: Force 2-2PCH

Problem
The Electrosurgical Generator activated without user pressing the activation button on the pencil.
Our observation is that fluid (blood) may be entering into the pencil at a very small gap in the union of two pieces of the handpiece. We can see a small bubble produced at this location when pressing on one of the buttons. There appears to be fluid internal at this location. I will e-mail you a picture showing this location. We have contacted the vendor to let them know. The response was no one else had this problem.


Device
Type: Integrated Wall Panel For Aneroid Manometer, Otoscope, Thermometer
Manufacturer: Welch Allyn, Inc.
Brand: Green Series 777
Cat #: 77790-3,4,5

Problem
Equipment panel hanging above the patient's bed fell off bracket and struck the patient in the forehead. The panel is fastened to the wall using an L-shaped bracket provided by the manufacturer. The bed was not against the wall and the wall was not touched by staff or other. The bed was being moved into an upright position by a nurse at the time of the incident. The panel in question holds several instruments, including an otoscope, a thermometer, and blood pressure cuff. The patient was taken for a CT scan, with negative results other than minor soft-tissue damage. The biomed staff has concerns with the way the panel is designed in the back in that it could be inadvertently knocked off the wall as it is only held by gravity. Our 'work around' has been to screw in the center of the bottom of the panel to the wall, so it cannot be lifted up. We have made the manufacturer aware of the issue.


Device
Type: Pump, Infusion, Enteral
Manufacturer: Covidien
Brand: Kangaroo Joey
Model#: 182510

Problem
Approximately 0900 pump alarming occlusion. Troubleshooting did not result in fixing this issue. Directions followed per manufacturer guidelines. Pump and tubing exchanged and no further issues experienced. patient was receiving tube feeding continuously at a rate of 95cc/hr. (Promote with fiber) Nurse was troubleshooting for approximately 30 minutes prior to exchanging for a new set up. 10am blood sugar =52. Insulin drip protocol followed and patient received 20ml D50 and insulin infusion stopped per protocol. 10:15 blood sugar=103. Patient was asymptomatic. Involved pump and tubing returned to clinical engineering for their assessment of the equipment. It was determined by clinical engineering to be a tubing issue; Epump safety screw spike set in stock is defective and needs to be removed from all stock and the manufacturer rep notified. The same tests were performed on two Joey pumps with the same result. Three Joey pumps were sent to Clinical Engineering for failing to deliver solution.

Device
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Covidien
Brand: Kangaroo Safety Screw Spike
Cat #: 775659

Problem
Approximately 0900 pump alarming occlusion. Troubleshooting did not result in fixing this issue. Directions followed per manufacturer guidelines. Pump and tubing exchanged and no further issues experienced. patient was receiving tube feeding continuously at a rate of 95cc/hr. (Promote with fiber) Nurse was troubleshooting for approximately 30 minutes prior to exchanging for a new set up. 10am blood sugar =52. Insulin drip protocol followed and patient received 20ml D50 and insulin infusion stopped per protocol. 10:15 blood sugar=103. Patient was asymptomatic. Involved pump and tubing returned to clinical engineering for their assessment of the equipment. It was determined by clinical engineering to be a tubing issue; Epump safety screw spike set in stock is defective and needs to be removed from all stock and the manufacturer rep notified. The same tests were performed on two Joey pumps with the same result. Three Joey pumps were sent to Clinical Engineering for failing to deliver solution.


Device
Type: Ventricular (Assisst) Bypass
Manufacturer: Thoratec
Brand: Heartmate Ii System Controller
Lot #: 105109

Problem
While adjusting the clock on the system monitor due to daylight savings time, the nurse hit the "Synch button" to synchronize the monitor and the controller clocks and an alarm occurred as follows..."CHANGE SYSTEM Controller, CHANGE BACKUP BATTERY or similar". The pump/controller continued to operate without problems. The alarm could not be resolved without replacing the controller.

Device
Type: Attachment, Breathing, Positive End Expiratory Pressure
Manufacturer: AMBU Limited
Brand: Airlife
Model#: 2K8080
Lot #: 131028
Cat #: 2K8080

Problem
During manual ventilation with Ambu bag during transport of an intensive care unit (ICU) patient from Emergency Room CT Scanner to medical intensive care unit (MICU), the Respiratory Therapist noticed that the positive end expiratory pressure (PEEP) valve did not fit as tightly as it used to. Then, the PEEP valve fell off of the Ambu bag. The PEEP valve was set at 15 cm H2O. The patient needed cardiopulmonary resuscitation (CPR) immediately following the loss of the PEEP valve. The patient was successfully resuscitated. Later, the Respiratory Therapy Manager found out that the PEEP valve had changed, but the distributor and catalog number were the same (entirely different PEEP valve than previously stocked PEEP valve). Distributor never told facility about this change in PEEP valve. A formal complaint was lodged with the distributor over this oversight and lack of communication. A formal complaint was lodged with Carefusion as there was no communication regarding the change of the PEEP valve product's specifications.

Device
Type: Mayfield Skull Clamp
Manufacturer: Integra LifeSciences Corporation
Brand: Mayfield Infinity Xr2
Model#: A-2079

Problem
Physician's assistant (PA) placed patient in new model - translucent Mayfield headrest- for procedure prior to me entering the room. While prepping and positioning the patient, the PA went to start shaving the operative site on the back of the patient's neck. Before she even touched the patient to start shaving, we heard a "click," she grabbed the patients head, and started looking to see what the click sound had been. She quickly found out that the plastic screw that holds the device together had broken and the patient's head was no longer being held up by the head rest. We obtained the "old" Mayfield and re-positioned the patient using that device.

Device
Type: Gas-machine, Anesthesia
Manufacturer: GE healthcare, Inc.
Brand: Aisys

Problem
Once the patient intubated, the positive end-expiratory pressure (PEEP) was measuring 10 cm. The anesthesia machine PEEP was set at 0cm(zero), with PEEP measuring 10 cm. The machine was then turned off, and the patient was ventilated by hand with an Ambu bag with 100% oxygen. The lungs were determined to be clear but the patient's heart rate (SVT) was 140bpm, they were also hypotensive.

Device
Type: Microscope, Surgical
Manufacturer: Carl Zeiss Meditec, Inc.
Brand: Lumera 700
Model#: LUMERA700

Problem
The resight, part of the microscope, fell off (the screw which holds the resight came loose) and landed on the right neck of the patient - contaminating the sterile field.

Device
Type: Catheter, Urological
Manufacturer: C.R. Bard, Inc.
Brand: Lubri-sil
Lot #: NGXH3935
Cat #: 942208

Problem
Patient had an 8 Fr Foley catheter ordered to be removed a week after it was inserted. RN tried to allow the syringe to self fill after attaching it to the catheter. Only 4 cc filled the syringe, so RN gently aspirated the remaining 1 cc. RN then removed the catheter from the patient. Some resistance was noted on this removal and upon inspection of the catheter after removal, a ridge was noted at the end of the Foley (balloon area, distal to tip).


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Updated June 1, 2014

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