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U.S. Department of Health and Human Services

MedSun: Newsletter #84, May 2013

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Newsletter #84, May 2013

Articles

Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

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FDA MedWatch Safety Alert

Damage from battery leakage may cause the device to shut off without warning. The clinical impact of a delay and/or interruption in therapy is dependent upon the clinical condition of the patient and the product being infused. Health care professionals are advised to weigh the risks and benefits to patients before using the device to administer critical therapies.

Additional Information:

FDA MedWatch Safety Alert. Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage. May 1, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349896.htm

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Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall

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FDA MedWatch Safety Alert

The recall is in response to customer reports of Newport Medical Instrument’s HT70 Ventilator and HT70 Plus Ventilator alarming and going into internal backup battery sooner than expected, while the ventilator is being operated on Power Pac battery. These conditions have been reported in two types of situations.

Additional Information:

FDA MedWatch Safety Alert. Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall. May 1, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350438.htm

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GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall

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FDA MedWatch Safety Alert

The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new information in its place (over-write) when the device turns “on” or recovers from a power failure. When this occurs, the heater or oxygen delivery option will turn “off” and the new set point will be “0”. In addition, alarms may not appropriately alert users that heater or oxygen delivery options are “off” or that the set points are less than intended.

Additional Information:

FDA MedWatch Safety Alert. GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall. April 24, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349283.htm

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LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall

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FDA MedWatch Safety Alert

At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 600 mg/dL” as intended. When turned back on, the meter enters the “Set-Up” mode and requires the user to confirm the date and time settings before being able to test again. However, if the glucose level is still measuring1024 mg/dL or above when testing, the meter will shut down again.

Additional Information:

FDA MedWatch Safety Alert. LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall. April 23, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349187.htm

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CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall

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FDA MedWatch Safety Alert

When the Alaris PC unit experiences a communication error, the programmed infusion(s) will continue as programmed. However, no further key presses on the Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device. Powering down of the device results in termination of all infusions. Termination of an infusion could result in serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall. April 22, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349002.htm

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Medical Bed Mattresses: FDA Safety Communication

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FDA MedWatch Safety Alert

From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress. The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

Additional Information:

FDA MedWatch Safety Alert. Medical Bed Mattresses: FDA Safety Communication. April 19, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348677.htm

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BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall

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FDA MedWatch Safety Alert

Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death. On Feb. 6, 2013, Smiths Medical sent its customers an "Urgent Medical Device Field Safety Notice-Recall".

Additional Information:

FDA MedWatch Safety Alert. BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall. April 9, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm347235.htm

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Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized

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FDA MedWatch Safety Alert

Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX were stolen from the manufacturer before they were sterilized. Although these devices were packaged and labeled as sterile, they are not sterile. The FDA is aware that some of these stolen and unsterile products have been offered for sale. The use of these non-sterile products could increase the risk of infection in surgical patients. The only way to identify the stolen, unsterile products is to check the Reference Code and the Lot Number on every box of Covidien Surgical Stapler Reloads prior to use. Do not use Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads labeled with Reference Code 030458 and Lot number N3B0165LX.

Additional Information:

FDA MedWatch Safety Alert. Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized. May 7, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351052.htm

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Discussions with Healthcare Providers

Batteries in Medical Devices: Small Sample Survey Summary

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Survey Topic: Batteries in Medical Devices - Summary of Responses
Year Conducted: 2013


Background:

Batteries are an essential component of many electrically-powered medical devices such as automatic external defibrillators, infusion pumps, physiologic monitors, and ventilators. It is widely known that batteries contribute to device reliability and battery failures can play a significant role in medical device failures. Battery failures can lead to serious adverse events and deaths.

There are several types of batteries used in medical devices including standard alkaline, rechargeable, and custom made batteries for a specific device. As more medical devices are becoming computerized, compact, and mobile, the prevalence of battery use has increased. When faced with a medical emergency and power is not available, or is intermittent or unreliable, the effectiveness and reliability of back-up battery-powered medical devices used for patient care becomes essential.

The purpose of this survey is to enhance FDA’s understanding of how batteries are used, maintained, fail, and how FDA can work with device manufacturers to improve battery reliability. This information is intended to contribute to improved performance of these devices.

Survey respondents include nine health care professionals who are Biomedical and Clinical Engineers, Risk Managers, Nurses, Attorneys, and Purchasing Directors working in MedSun hospitals on the east coast, the mid-west, south, and southeast regions of the country. The information that follows is a summary of their responses to the survey questions.

Summary:

The most common battery-powered medical devices used by the nine respondents are listed in Table 1. Of the devices listed, the respondents state that the most frequent problems are associated with large volume infusion pumps, telemetry boxes, pulse oximeters, thermometers, electric beds, monitors, and portable/mobile devices. Table 2 lists the most common battery-related problems reported by the respondents. Many of these problems, especially those related to large volume infusion pumps, may be attributed to staff practices. All nine respondents indicate that most problems with infusion pump batteries stem from the failure to plug in the pump or from under- or over-charging the pump by hospital staff resulting in premature depletion, loss of power and in some cases, fire.

Table 1. Most Common Battery-Powered Medical Devices Used by Respondents

Diagnostic DevicesInfusion Pump DevicesLife Support DevicesOther Devices
*Physiological monitors*Large Volume PumpsVentilators*Portable lights
*Non-invasive blood pressure machinesSyringe PumpsDefibrillators*Portable X-rays
*Telemetry packs and boxesPatient controlled anesthesiaTemporary external pacemakers*Portable computer stations
Electrocardiograms Heart/lung machines*Electric beds
*Pulse oximeters Anesthesia machinesPatient lifts
*Thermometers Intra-aortic balloon pumpsSequential compression devices
Aspirators
Isolettes/warmers
Feeding pumps
Suction pumps
Biphasic positive airway pressure machines
*Devices with recurrent battery-related problems reported by respondents

Table 2. Battery-Related Problems Reported by Respondents
Battery-related problemsReported Outcomes
*Failure to plug-in device when not in usePremature depletion; loss of power
*OverchargingOverheating; fire; explosion
*UnderchargingPremature depletion; loss of power
*Inaccessible plugs/outletsPremature depletion; loss of power
LeakageFire
SwellingExplosion
Confusion with on/off button on pumpPremature depletion; loss of power
Loose connection between electrical cord and devicePremature depletion; loss of power
Incorrect replacement battery by staffLeakage; increased hot temperature; ignites fire
*Most frequently reported battery-related problems by respondents

All nine respondents report that nursing staff is responsible for charging battery-powered medical devices on the units where they are used. However, staff either forgets to plug in the devices or outlets/plugs are not available when needed. Although all report providing ongoing training to reinforce the need for plugging in devices, staff often fail to do so even when outlets/plugs are available. This is particularly true after transport devices have been used to move patients from one location to another; staff does not remember to plug in the transport devices in the new locations. Two respondents attribute this problem to several factors, such as work pressures in the clinical area, constant transport of patients and devices between locations, and staff who tend to focus more on patient care tasks rather than charging the devices.
Three respondents have added outlets in patient rooms and storage areas. One of these also added power outlets attached on IV poles to improve accessibility for staff. This particular respondent also moved plugs from the head of patient beds to the side of the beds for easy access. For aesthetic reasons, this respondent has placed outlets in the cupboards in patients’ rooms, although these are cumbersome for some staff to use. Two respondents mention having to replace plugs worn out from use by so many battery-powered devices. One respondent meets with nursing staff to show the costs for replacing pump batteries when they are depleted (approximately $30.00 to $40.00 per pump each time), and notes that when staff understand the cost implications, the problem of not plugging in devices significantly decreases, thus preserving the life of the batteries.

All respondents express concerns about inappropriate battery charging. Three report that frequent over-charging results in deformed batteries, swelling, over-heating, fire, and explosion. Of these three respondents, two have stopped using third-party batteries because of the frequent swelling and over-heating. When a battery swells, it is difficult to remove it from the device.
Typically, undercharging occurs when the device is not plugged in long enough for the battery to completely recharge. This is particularly true of patient transport devices. Staff may charge the device for only 15 minutes when it may need to be charged for seven to eight hours. There is no message or other visual indicator specifying how long the device has been plugged in or if it is fully charged. Another respondent shares that when an infusion pump is not fully charged after transport and then is unplugged and used for transport again, batteries deplete, pump function is minimized and it may trigger several alarms. The alarms occur because the pump is trying to charge the battery and function at the same time. Not all devices have a “low battery” alarm, so when the battery is not fully charged error codes are displayed instead. Two respondents stated that pulse oximeters frequently show error codes as a result of undercharging. One suggestion to alert staff to the battery status, is to have the manufacturers add green, yellow and red LED lights on the devices that change color when the battery status changes.

Another issue affecting battery charging is staff using an incorrect battery for replacement. A respondent relates an incident when an incorrect battery was replaced in a Doppler. The Doppler worked fine initially, but the battery lost its rechargeable capabilities over time and didn’t work. The battery leaked and over-heated. While no patient adverse event occurred, the problem disrupted patient care. In another event, a respondent relates that a battery exploded after sitting idle on a shelf for months. In addition, batteries that are stored on a shelf or in a room and not used for months can swell or deplete. One respondent reports that batteries in some rental beds and infection controlled purified air devices may leak and explode after sitting idle for months. Some non-invasive blood pressure monitors have on/off switches on the front and back of the device. One on/off switch is for powering on the device and the other on/off switch is for charging the device. Staff is often confused about the light indicator on the device and whether it means the device is charged or powered on. Additionally when the battery gets low, there is no warning; it just shuts off.

In response to questions regarding labeling for battery-powered devices, six respondents say that labeling and the instructions for use (IFUs) are clear and contribute to proper use and maintenance of the devices, one respondent is not sure, and two believe the labeling is not adequate. The IFUs/manuals state to keep devices charged when not in use; however, in everyday practice it doesn’t help because the IFUs/manuals generally are not on the nursing unit with the device, and for reasons noted earlier (e.g., staff is too busy to remember to plug in devices, etc.), the IFUs are not followed. Some manufacturers provide a quick guide or shortened version of instructions that recommends keeping the device plugged in; however, the length of time needed for charging batteries is not always stated. All respondents add stickers or labels on the front of the device or attach laminated cards to remind staff to keep the device plugged in. However, sometimes the laminated cards fall off and staff throws them away. One respondent suggests that manufacturers add permanent bright orange labeling on devices to remind staff to charge the device, and another suggests that manufacturers eliminate the need for manual battery charging.
All nine respondents indicate that it would be very helpful if devices that have been shut off would alarm alerting staff that the devices should be plugged in. As stated previously, when some devices are not fully charged, they alarm frequently or error codes appear. After the devices are charged overnight, the error codes usually go away and they work fine. One respondent reports that one manufacturer’s infusion pump batteries frequently deplete because the pumps are not plugged in for charging or they may not be charging while plugged in. This particular respondent replaces an average of 30 to 40 batteries per week. When batteries in older pumps deplete, they can still be used with AC power.

All respondents suggest consistent, ongoing staff education and training in the proper use of devices, placing more emphasis on plugging in devices. One respondent proposes that new training material by itself will not change staff culture. Instead, the respondent suggests manufacturers design a product that will make it easier to detect the charge level of batteries, such as adding a feature to batteries similar to a gas gauge. Another suggestion is that manufacturers develop standard, easy to read indicators or symbols for batteries, i.e., battery time left, charging time, etc. Currently, where these do exist, they are different from one manufacturer to another.

The respondents did not report any battery-related deaths or injuries; however, one individual commented on potential for harm events that occur when the hospital loses power during storms. Infusion pumps and Uninterruptable Power Systems (UPS) replacement batteries are most troublesome when the power goes out and they don’t work. As a result, this respondent changes UPS batteries as frequently as the batteries in infusion pumps, which is a couple of changes every month. On one occasion when the hospital lost power during a storm, the emergency generator powered on after a five to six second delay. When the hospital power returned, the temperature settings on an infant warmer/isolette defaulted to the manufacturer setting and the isolette became too hot. The battery safety circuit had over-heated and the change in temperature was identified by one of the nurses. There was no harm to the patient. One respondent believes that not only high risk devices should always be plugged in unless they’re in transport, but also handheld devices such as pulse oximeters, telemetry boxes, and thermometers. Another respondent reports near misses with low or depleted batteries in temporary external pacemakers. Staff has no idea that the battery is low or depleted until it happens and only has two to five seconds to change the battery before a patient is compromised. This device performance can improve with an alarm. In addition, battery cells can go bad in a MRI conditional patient monitor even if the device is plugged in (the manufacturer is aware of this problem).
The percentage of battery-related service calls reported by the nine respondents, range from 8% to 50%. The biomedical/clinical engineers or hospital technicians are responsible for replacing batteries, especially if the battery case has to be opened. In one hospital, the Central Supply Department is responsible for replacing batteries in devices that are locked in code carts and the Respiratory Department is responsible for replacing batteries in respiratory equipment.

All nine respondents have preventive maintenance (PM) schedules for servicing and proactive replacement of batteries. One of the nine respondents only has PM schedules for devices that use a UPS. The PM schedules are based on the level of device risk and manufacturer recommendations and ranges from six months to five years. Respondents say some devices require battery replacement based on “hours of usage.” Two respondents follow the manufacturer’s recommendations for battery replacement. One of the two will replace the battery even if the battery is working. Another replaces batteries proactively based on device inspections, tracking, and service minutes. One other respondent indicates that when they conduct preventive maintenance, any device with a battery is tested to exercise the battery. In one respondent’s hospital, batteries in portable x-ray units are replaced by an outside vendor.

Most of the respondents, except one, track all battery-related service history calls and work orders electronically or they are in a manual log. Another individual also tracks codes for physical damage that occurs when the device is dropped on the floor, run into, or crushed. The processes and factors that all respondents consider before purchasing batteries are very similar. Table 3 lists the processes. Two respondents report they no longer purchase certain batteries for High Risk or Tier 2 devices because of frequent battery swelling. One of these two respondents describes a situation where a monitor caught fire and burned as a result of battery swelling. Another respondent purchases rechargeable batteries, although they are not always compatible with certain devices because they don’t always have the amps required for the device function, and yet another evaluates two manufacturers’ batteries before making a purchase. If a generic battery can be used, most will purchase an equivalent battery and add that it’s a performance as well as an economic issue. In one hospital, the biomedical engineers purchase rechargeable batteries and the hospital units purchase disposable batteries. In two other hospitals, respondents tell their corporate contract department what they want and the department finds the best price and purchases the batteries. If a custom battery is required, all respondents state they are locked into buying from the manufacturer, although they can be very expensive. One respondent states they will save a lot of money if they can use disposable AA batteries for their telemetry units, instead of rechargeable batteries.

Table 3. Processes and Factors Considered When Purchasing Batteries
Processes
High risk or Tier 1 devices: custom made, proprietary, or a specialty battery purchased from the device manufacturer
Low risk or Tier 2 devices: rechargeable, third-party or generic batteries purchased from any company
Factors
Cost
Facility equipment needs
Quality of battery life
Technical specification
When asked how FDA can help respondents address medical device battery-related issues to reduce the occurrence of failures, some respondents indicate a need for better labeling and other related factors. Table 4 lists ways the respondents state that both FDA and manufacturers can help address battery-related issues. One respondent states that manufacturers should seek more input from users, particularly when designing large volume infusion pumps. Infusion pumps use battery technology to a considerable degree and can only be reset by biomedical/clinical engineers, which becomes a cost and labor issue.

Table 4. How FDA and Manufacturers can address medical device battery-related issues
Education and trainingFDA/MedSun provide potential for harm education and training, cognitive-based web training, focus groups, and case studies
Recalled batteriesFDA/MedSun provide access to recalls and alerts and note the specific battery used in recalled devices, and if the battery problem is associated with a root cause.
Performance dataFDA/MedSun track and present performance data, including device failures, on batteries from different battery manufacturers.
LabelingManufacturers provide stickers, posters and permanent labeling on devices to remind staff to plug in devices, time intervals to inspect devices, and servicing.
WarningsManufacturers provide visual indicators (lights) on infusion pumps for ‘low battery’ and ‘end of battery life’status.
StandardsManufacturers provide standards for battery charging, replacement, service intervals, and disposal of batteries.
Battery technologyManufacturers provide access to inside a battery compartment to check a cycle. Design devices that don’t require manual charging, and rechargeable instead of disposable batteries.
Battery testingManufacturers reclassify and provide testing information that is currently proprietary.


The following is additional information provided by respondents to support this project:

  • A battery was over-charged in an infusion pump because gas was entrapped in the chassis. The battery ignited and the infusion pump exploded.
  • One respondent has numerous infusion pumps approaching end of life that need repair quite frequently. More than 25 batteries are replaced weekly and it takes one hour per pump making it the most timely and costly device. An engineering work station is used just for infusion pumps and in the future the facility may replace their current pumps.
  • Glucose meter batteries don’t provide battery replacement information. If the manufacturer will give an estimate of time for replacement, the respondent can proactively evaluate battery life. Nurses will not have to count how many times they charge the batteries.
  • In one hospital, more than 50% of the equipment is owned by specific departments. No one person has ownership to monitor batteries. One department is responsible for and provides battery boxes for recycling lead acid, rechargeable, and alkaline batteries. The Hazard Materials staff is responsible for all other batteries.


Special Studies and Surveys are two of many tools the FDA uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Typically, small sample surveys are used to collect qualitative information on postmarket experiences of clinicians or facilities with medical device performance or use. Survey respondents are selected based on their experience with the topic device and their willingness to participate. Thus, these findings may not be generalized to all users of a device. The FDA continues to evaluate adverse event reports from its Medical Device Reporting program, the medical literature and other postmarket data sources as part of its ongoing monitoring of device performance. FDA scientific, medical, nursing and engineering staff is made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, 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, FDA may convene an Ad Hoc group of clinical, scientific and regulatory experts to discuss further actions.

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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 April 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Accessories, Cleaning, For Endoscope
Manufacturer: Custom Ultrasonics
Brand: System 83 Plus 9

Problem:
Around mid-day one of the techs noticed that detergent wasn't flowing from the gallon pump bottle into Bay 1 of the reprocessor; Bay 2 was fully functional and continues to work properly. Endoscopy personnel were asked to use only scopes that had been reprocessed in Bay 2. In attempting to determine which patients may have been affected, we discovered that the electronic data for the machine is either inaccessible or irretrievable at this time. The service technician believes we may be able to gain access to the data, but a special code is required. He is currently working on getting the code and has also been asked to perform a site visit as soon as possible to address the problem with Bay 1. We attempted to determine when detergent was changed last and were unable to. Usually techs replace the bottles when they run low-about every 1.5 weeks

======================
Manufacturer response for Olympus Reprocessor, Custom Ultrasonics 83+9" (per site reporter)
======================
There is no alarm or notification on the printout when detergent doesn't reach the machine.
The machine is certified for both washing and Disinfection; although the use is "off-label", it can be used just for disinfection.
By following the cleaning criteria described (utilization of pre-cleaning and Scope Buddy), there is no increased risk from a patient standpoint.
No violation.
No need for patient notification.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology
Brand: Sternal Cable System
Model#: 400-690
Lot #: 139998

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.



Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology, Inc.
Brand: Sternal Cable System
Model#: 400-690
Lot #: 142013

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology, Inc.
Brand: Sternal Cable System
Model#: 400-690

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology; Inc.
Brand: Sternal Cable System
Model#: 400-690
Lot #: 139998

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Device, Neurovascular Embolization
Manufacturer: MICRUS ENDOVASCULAR
Brand: Deltaplush Microcoil
Lot #: G13507
Cat #: CPL 100256-30

Problem:
Coil did not detach during attempted embolization of an aneurysm. Physician was able to pull the entire coil out without harm to the patient.


Device:
Type: Hypothermia Unit
Manufacturer: Cincinnati Sub Zero
Brand: Electri-cool Ii
Model#: 767

Problem:
Patient had a cooling pad on his right knee per protocol after a right total knee replacement. R.N. caring for patient identified that the water in the hypothermia unit was hot to the touch, the tubing was warm and the patients knee was warm. R.N. removed machine, placed ice pack to right knee and obtained new machine. Machine was inspected by biomed. range on machine is set for 5-7 degrees Celsius, however when machine was tested it was at 15 decrees Celsius


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Becton Dickinson
Brand: Bd Precisionglide
Lot #: 1214753
Cat #: 305122

Problem:
Patient undergoing eye surgery for treatment of glaucoma. Surgeon noticed shiny speck in iris of right eye. Further evaluation noted tip from an injection needle had broken off. The surgeon decided to leave the particle in the eye. An attempt was made to remove the particle, but this was embedded in stroma and the more removal attempt was made as the bigger the wound became. He decided at this point to leave the particle in the cornea. This particle was approximately 0.1 mm in size. It was buried in the stroma. The surgeon did not believe it will cause any long-term difficulties. There was additional follow up on the patient by the surgeon the next day for evaluation. No one has an idea of what may have contributed to this event.


Device:
Type: Set, Blood Collection
Manufacturer: Becton, Dickinson & Company
Lot #: 3047784
Cat #: 367344

Problem:
This morning the Lab Supervisor identified an issue with recent shipment of BD item REF 367344 green butterfly needles, Lot#3047784, expiration date of 02/2015. The Lab Supervisor notified the BD rep of the issue. There is a defect in some of these that can be visually seen as holes in the tubing. This appears to be a recent lot shipment. We have pulled all of this item from Lab and Network Reference Lab draw sites and have them in the lab.


Device:
Type: Supplies, Blood-bank
Manufacturer: Typenex Medical, LLC
Brand: Barcode Blood Band For Handwriting
Lot #: M081612
Cat #: 4R4610
Other #: Series HRI

Problem:
Feedback from our post-partum obstetrical nursing manager that the Typenex bracelets for mothers & their newborns are deteriorating. The plastic cellophane covering is peeling off. A new mother who was breast feeding became very alarmed when a small piece of the cellophane covering fell on to her breast while nursing her newborn. No patients have been harmed. The bracelets are in place for 1-3 days. These bands are used to identify individual patients and to match the correct mother to the correct infant.

1) Post-partum unit collected 5 more examples of unacceptable bracelet. All bracelets were on patient for less than 3 days and deteriorated. All 5 bracelets were essentially illegible.
2) The product code 4R-46-10- confirmed lot (01)892159002024(10)M081612 Typenex series HRI as a problematic lot. There are other lots that have same problem, in particular lot with Typenex series HSE.

======================
Manufacturer response for Typenex Bracelet, Barcode Blood Bank Bands for Handwriting Catalog Code -4R4680 Yellow (per site reporter)
======================
Per e-mail from Regional Acct Mgr, "Please send the effected band samples to the address below included with my signature. Once we receive the bands we can complete testing and come up with reasons for why this is happening as well as next steps. I am not aware of any changes in material or production that have been made to your current band. It would be helpful if you can provide lot numbers associated with the bands."


Device:
Type: Supplies, Blood-bank
Manufacturer: Typenex Medical LLC
Brand: Barcode Blood Band For Handwriting
Cat #: 4R4680
Other #: Series HSE

Problem:
Feedback from our post-partum obstetrical nursing manager that the Typenex bracelets for mothers & their newborns are deteriorating. The plastic cellophane covering is peeling off. A new mother who was breast feeding became very alarmed when a small piece of the cellophane covering fell on to her breast while nursing her newborn. No patients have been harmed. The bracelets are in place for 1-3 days. These bands are used to identify individual patients and to match the correct mother to the correct infant.

1) Post-partum unit collected 5 more examples of unacceptable bracelet. All bracelets were on patient for less than 3 days and deteriorated. All 5 bracelets were essentially illegible.
2) The product code 4R-46-10- confirmed lot (01)892159002024(10)M081612 Typenex series HRI as a problematic lot. There are other lots that have same problem, in particular lot with Typenex series HSE.

======================
Manufacturer response for Typenex Bracelet, Barcode Blood Bank Bands for Handwriting Catalog Code -4R4680 Yellow (per site reporter)
======================
Per e-mail from Regional Acct Mgr, "Please send the effected band samples to the address below included with my signature. Once we receive the bands we can complete testing and come up with reasons for why this is happening as well as next steps. I am not aware of any changes in material or production that have been made to your current band. It would be helpful if you can provide lot numbers associated with the bands."


Device:
Type: Gas-machine, Anesthesia
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC.
Brand: Apollo
Model#: Apollo 8606500-52

Problem:
Patient undergoing hypospadias repair. ASA 2. Patient with LMA breathing spontaneously on Sevoflurane exhibiting elevated expirated CO2 levels (60-78) during surgery. Patient was placed on pressure support with a resulting reduction in expired CO2 from 80-60 for the remainder of the case.
Surgery concluded no sequelae.


Device:
Type: Gas-machine, Anesthesia
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC
Brand: Fabius Gs Premium
Model#: 860700055

Problem:
Patient undergoing an orchipexy for undescended testicles. ASA 1. Patient with LMA breathing spontaneously on Sevoflurane exhibiting persistent elevated expirated CO2 levels (60-80) during duration of surgery. Surgery concluded no sequelae.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St Jude Medical
Brand: Angioseal Evolution
Other #: 23417-000

Problem:
The integrated "tamp-tube" did not slide down upon withdraw of the device. Added tension in the device was felt. CV tech had to fillet the end of the sheath to extract the "tamp-tube" and manually slide and pact the collagen onto the arteriotomy. Due to having experience with this similar event, the device was able to be deployed with minimal to now bleeding in the access site.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St Jude Medical
Brand: Angioseal

Problem:
The integrated "tamp-tube" did not slide down upon withdraw of the device. Added tension in the device was felt. CV tech had to fillet the end of the sheath to extract the "tamp-tube" and manually slide and pact the collagen onto the arteriotomy. Due to having experience with this similar event, the device was able to be deployed with minimal to now bleeding in the access site.

NOTE: this is the fifth event this year with this device at our facility.


Device:
Type: Monitor, Physiological, Wall Mount
Manufacturer: Philips Medical System
Brand: Gcx
Cat #: AG-0021-25
Other #: MP50

Problem:
During routine servicing on the monitor, the clinical engineer grabbed the monitor to lift it up and his fingers got pinched between the cable organizer bracket and the arm. It happened because the organizer bracket is able to spin around. The risk is for anyone adjusting the height of the monitor, either nursing or biomed employees who place their hands in an incorrect position near the GCX monitor mount.


Device:
Type: Oxygenator, Cardiopulmonary Bypass
Manufacturer: Medtronic, Inc.
Brand: Medtronic Affinity Carmeda Oxygenator
Model#: Affinity
Lot #: 206208584

Problem:
Medtronic oxygenator was found to have an area that was cracked and sheared off during a coronary bypass surgery. This happened as the perfusionist was setting up his equipment to prepare for cardiopulmonary bypass (prior to the pump being started). A huge hole blown in top of unit and luer connection sheared off. There have been at least six other occurrences at a near by hospital for this product. Surgeons have expressed the use of this device is concerning.


Device:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: ICU Medical, Inc
Brand: Transpac
Model#: 42584-05
Lot #: 2613339

Problem:
On at least three occasions, the Transpac IV tubing "snapped" at the connection just proximal to the flush adaptor leaving the male connector portion within the female. The tubing was under pressure, however staff report the pressure bag was not over-inflated at the time of either incident. When the tubing separated it created the potential for an "open" system (unless either of the two distal stopcocks were turned off to the patient). It also allow fluid, under pressure, to saturate the surrounding area unless the roller clamp was quickly closed. The remaining kits, with the same lot number, were removed from stock and no further incidents have been reported.


Device:
Type: Wire, Guide, Catheter
Manufacturer: TERUMO MEDICAL CORP
Brand: Stiff Shaft
Lot #: 110906
Cat #: GS3805
Other #: 0.038 inches, 150 cm, 3 cm flex tip angled stiff shaft glidewire

Problem:
Physician gained vascular access through a venous fistula utilizing the outbound tract. Vessel had arterialized pressure. Venograms were performed times two. An occlusion of the subclavian vein was visualized by the venogram. Attempts were made by physician to recannulize the occluded vessel. Physician asked for a .038 cm Stiff Shaft Glidewire to attempt re-opening the occluded vessel. The distal tip of the stiff shaft glidewire has an angled tip and is semi-flexible. The proximal end of the glidewire is very stiff, and relatively inflexable. The angled tip of the glidewire was inserted into the long sheath introducer. Attempts to cross the occlusion was not successful. The physician then turned the glidewire around, and inserted the proximal stiff end into the introducer and attempted to cross the lesion.
It was noted that the wire perforated the blood vessel. The physician upon seeing the issue, removed the wire and cancelled the procedure. Vital signs according to the nurses and technicians involved in the case remained stable. The patient was returned to the nursing unit for post procedure observation and care. It is questionable if the use of the wire was appropriate following manufacturer guidelines for use.

Upon review of package literature, and talking with the manufacturer territory sales representative, there is no documentation suggesting that the proximal end of the guidewire cannot be utilized during the procedure. It falls to the judgment of physician to determine appropriate use of the wire.


Device:
Type: Tray, Catheter, Foley
Manufacturer: Bard Medical
Brand: Complete Care Lubri-sil I. C.
Lot #: ngwk1701
Cat #: 300416A

Problem:
Patient with latex allergy had a latex foley inserted - no harm to the patient upon discovery. Foley was removed and patient treated with steroids.

Human error - staff concerned with look alike packaging for the latex free and the latex Foleys.

The packaging has the the same color fonts, packaging labeling for latex free Foley to the right of label it is written "latex free" same color print. The label slides within the packaging during shipping. making it difficult to the read "latex free" text.


Device:
Type: Hemostatic Matrix
Manufacturer: Baxter Healthcare Corp.
Brand: Floseal
Lot #: 121218
Cat #: 1503350
Other #: Case of 6

Problem:
Floseal matrix never dissolved with the thrombin/saline mixture. Defective product. Unable to mix items for use. Product removed -not used. Another Floseal product used without problem. This never went into the patient.


Device:
Type: Chair, Medical, Examination
Manufacturer: Stryker Medical
Brand: Symmetry Plus
Model#: 3500-000-710
Cat #: 3500-000-710

Problem:
Patient in recliner to be examined. Nurse Practitioner pulled the footrest handle to elevate the feet and it snapped sharply upward. Patient complained she heard a loud pop in her left knee and a few minutes later it started to cause pain and swelling. Examination showed some swelling. X-ray showed moderate effusion and next day patient was in pain. Patient had MRI which showed large hemorrhagic joint effusion of left knee with no major structural anomolies identified. Possible strain of bicep femoris muscle.

Nursing in two different sites report workarounds with this chair as it does have a strong spring and can cause hyper-extension to patient's knees. They will hold the foot rest down with their hands or tell patient to hold feet up until the footrest is in place.


Device:
Type: Incubator, Neonatal
Manufacturer: GE Medical Systems
Brand: Giraffe Omnibed
Model#: Giraffe OmniBed

Problem:
This is a recurring issue with this model, not just this one device. The humidifier heater in the front, behind the water container gets very hot and weakens the area close to it. We then have to replace the chassis and sometimes the heater as well. This is a costly and time consuming repair. We sometimes replace the chassis in two years. Many times the chassis is not available and on back order, which increases the down time. Also the price of the chassis and heater have increased steadily.


Device:
Type: Lift, Patient, Ac-powered
Manufacturer: ArjoHuntleigh, Inc.
Brand: Maxisky 1000
Model#: LF21019

Problem:
Lift motor and gantry was assembled in the room for use with an 842 pound patient in mid-January 2013. Original lift motor failed to operate reliably due to weak or depleted batteries, charger problem, or other issues. It was replaced approximately 2 weeks later with a second motor. This motor would lift the patient but would not hold in position without slowly dropping downward.

The patient was then lowered back into the bed and disconnected from the lift. Using its control pendant, the lift motor was moved to its park position. Shortly after reaching the park position, with no buttons being pressed on its control pendant, the lift motor spontaneously moved from the park position toward the nurse and patient.

The lift assembly was then removed from the patient's room. It was reassembled within the Biomedical Engineering department for testing, and it was confirmed that a sequence of lift, release, and move to park position would result in spontaneous movement from the park position toward the opposite end of the gantry.
The lift was not used again, and was eventually removed by the vendor.

The manufacturer's representative present for testing, and observed spontaneous movement.


Device:
Type: Set, Administration, Intravascular
Manufacturer: CareFusion
Brand: Alaris
Cat #: MS3500-15

Problem:
The item numbers that were involved were; 2441-0007 (Burette Primary Pump Set), 2426-0007 (3 Port Primary Pump Set) and MS3500-15 (Secondary Set). When the RN was running a piggy back she would use the secondary set (MS3500-15) and hook this into the Burette Set (2441-007). She noticed a leak at the Y-Site where these two items connected. She then tried using the primary pump set (2426-0007) and again there was a leak. This helped the RN identify the issue being with the secondary set (MS3500-15) and not the other two items.

The following is response from our area Alaris Tubing rep to the hospital:
I have contacted my Clinical Nursing Consultants that cover Southern California because this secondary set (MS3500-15) is used in many local facilities. They have not been notified or seen this same issue in any other facilities. This leads me to believe that hopefully this issue was just with this one set and not an issue with a case/lot of MS3500-15. Based on this information I think it would be best for us to simply keep our eye on this and see if the issue happens again. I also will report to this to my clinical advocacy department who will follow up to research further.


Device:
Type: Uterine Manipulator
Manufacturer: Conmed Corporation
Brand: Vcare
Lot #: 130108-1
Cat #: 60-6085-202

Problem:
Balloon for this product would not work.

Three more or the same product were opened and all three failed.

All products from this lot have been pulled from the shelves and manufacturer to be notified.

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Updated May 1, 2013

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