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U.S. Department of Health and Human Services

MedSun: Newsletter #65, October 2011

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Newsletter #65, October 2011

Discussions with Healthcare Providers

Alarm Fatigue: MedSun Small Sample Survey Summary

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Survey Topic: Alarm Fatigue - Summary of Responses
Year Conducted: 2011



Background

This survey is an effort to learn about clinical experiences with medical device alarms, particularly the issue of alarm fatigue. In addition, FDA wants to understand other related issues that may occur with medical device alarms such as alarm discriminability, alarm volume and alarm activation thresholds.

Alarm fatigue is a clinical scenario that may occur when alarms sound so often that responders become desensitized to them and may not respond quickly enough or not at all. Alarm discriminability refers to the clinician’s ability to distinguish one medical device alarm from another to respond correctly to the actual alarm. Problems with alarm volume may occur when the alarm sound is not loud enough, can’t be adjusted to be loud enough for the responder to hear, or when settings have been changed and not reassessed frequently enough. Issues with alarm activation thresholds occur when the sensitivity levels for a given medical device alarm is adjusted based on a clinical situation or environment and is left at that setting and not readjusted for a new patient or new clinical situation.

The survey involved nine healthcare professionals from nine MedSun facilities. Two of the facilities are pediatric hospitals. Survey respondents include risk managers, staff nurses, nurse managers and biomedical engineers. The information that follows is a summary of responses.

Summary

During their shifts hospital staff encounter numerous medical device alarms and alerts which may lead to alarm fatigue. Six of nine respondents are familiar with the term alarm fatigue and describe it as becoming desensitized or immune to medical device alarms because there are so many. Those who are not familiar with the term say they are aware of the problem.

There are numerous medical devices with alarms. Respondents report the most commonly used devices with alarms are IV pumps, feeding pumps, ventilators, cardiac monitors, sequential compression devices, dialysis machines, nurse call systems, hospital beds, and chairs with exit alarms. Some additional devices in use with alarms include medication dispensing systems, extracorporeal membrane oxygenation (ECMO), and pocket phones, pagers, and telephones as secondary alarms. Seven respondents report that because of the barrage of sounds, instances of alarm fatigue occur on their nursing units every day.

Alarm fatigue is so common that it makes the ability to distinguish one alarm from another more challenging. When hospital staff hear a single alarm, or multiple device alarms they have several methods for identifying one from another. These methods include checking central monitors in the nursing station, searching room to room, using split screens in patient rooms, and recognizing sounds. The majority of respondents say their device alarms are loud enough to be heard from the central location on the unit. However, they report there are several factors that make it more difficult to hear alarms. These factors include the size and configuration of units, closed doors to patient rooms, and high noise levels on units.

Nearly all say they can distinguish urgent or critical alarms from all others most of the time because of a distinct difference in tone, sound, or rhythm. Many memorize the sounds to know the differences and say that over time staff learn the different tones. However, some respondents say that after staff are listening and responding to alarms for the duration of their shifts, the tones begin to blend together. In addition, one respondent reports that some device alarms sound identical, for example, patient beds and infusion pumps, making it even more difficult to distinguish which device is alarming.

In addition to auditory alarms, all respondents report that most of their devices have visual alarms. Visual alarms include blinking and/or colored lights, and monitors with pictures or text. Nearly all respondents find visual alarms helpful. Some respondents describe a visual “red” (critical) alarm that flashes along with the room call light at the central monitor that helps to quickly locate the alarm and the patient room. However, none thought that voice alarms on devices would be helpful. They believe that voice alarms would add to the noise and confusion on the nursing unit and think it would be even easier to tune out voice alarms than standard alarms. Also, they believe it may upset patients and their families.

Alarm activation thresholds are another critical concern involving medical device alarms. Half of the respondents say volume and parameter threshold settings are adjusted based on a patient’s clinical status and clinical judgment. Others say that default parameter settings are adjusted depending on the type of nursing unit such as the cardiac intensive care unit. Six of nine respondents say parameters are adjusted by unit nurses or other clinical staff. The remaining respondents have their biomedical engineering department make the parameter adjustments. When discussing silencing alarms, seven respondents say they are able to temporarily silence alarms for purposes of troubleshooting for a period of thirty seconds to three minutes. After this time frame, the alarm usually resets and turns back on. The majority of respondents say that serious alarms, such as those for lethal heart rhythms cannot be permanently disabled. And, according to nearly all respondents, once a patient is discharged from the device the alarm settings revert back to their default settings.

Respondents have several ideas about alarm modifications that may improve the safety and effectiveness of medical device alarms. One suggestion is increasing the use of “smart alarms.” An example of this is an IV pump occlusion alarm that self-corrects when the occlusion is the result of a patient who temporarily bends an arm with the IV or rolls on the tubing. Another suggestion is linking the apnea and oxygen saturation monitor alarms because apnea monitors are very sensitive and alarm even when oxygen saturations values are within set parameters. Also, many oxygen saturation alarms do not distinguish between values that are high or low. For example, the alarms for values of 89% and 30% are the same sound so different sounds would be more helpful.

Another suggestion is providing an escalating alarm or two different tones on cardiac monitors specifically for detecting bradycardia in infants. Having two distinct tones for bradycardia and tachycardia particularly for infants in neonatal intensive care units will help clinicians identify problems faster.

Also, several respondents say that when multiple alarms are sounding at once, it would be beneficial if the device could indicate the nature of the problem so the clinician can determine the type of response required. Examples of this include having different tones for a “leads-off patient” alarm versus an alarm for a critical patient issue, or an alarm that specifically indicates a high heart rate versus a low heart rate for an individual patient.

Respondents’ suggestions also include designing better technology to improve the safety and effectiveness of device alarms. These include providing clinicians with the ability to receive a text message about a device that is alarming on a smart phone, designing noise-cancelling technology for unit hallways, providing portable monitoring through use of a pad or tablet, and improving algorithms in monitor software for individual patients that are more accurate and can help eliminate false alarms. In the event of an alarm that is disabled, some suggest having a question appear on a monitor screen asking, “Do you want this alarm to remain off?” Also, many respondents believe that in addition to improving technology, working with physicians to establish criteria for patients that need monitoring and those that do not will also help reduce alarm fatigue and keep patients from being monitored unnecessarily.



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Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are 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 and manufacturing representatives to discuss further actions.

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Articles

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

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FDA MedWatch Safety Alert

H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

Additional Information:

FDA MedWatch Safety Alert. H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination. September 16, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm

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Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance

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FDA MedWatch Safety Alert

Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronic's analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance. September 12, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm271510.htm

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Take Precautions with Audible Alarms on Ventilators

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FDA Medical Device Safety

In 2010, the FDA received over 2,500 adverse event reports associated with ventilator use. About a third of these events indicated an alarm-related issue. Although some of these alarm-related adverse event reports reflected deteriorating patient condition, indicating that the ventilator alarms had functioned appropriately, many indicated preventable audible ventilator alarm malfunctions or human error.

Additional Information:

FDA Medical Device Safety. Take Precautions with Audible Alarms on Ventilators. September 6, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm270894.htm

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Physiologic Alarm Management

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Pennsylvania Patient Safety Advisory

Alarm management is a critical issue for all Pennsylvania facilities. The 35 patient deaths and 102 associated potential contributing factors that were reported to the Authority illustrate a wide variety of reasons for alarm management failure and suggest focus areas for improved alarm management strategies. Basic staff interventions (i.e., education regarding physiologic alarms, clear lines of responsibility for responding to alarms, discouraging silenced alarms) can be paired with equipment management interventions (i.e., scheduled equipment testing, replacement, and battery change; alarm audibility testing; policies for alarm default limits) for maximum impact. Facilities can also monitor for alarm desensitization in both primary care staff and remote monitoring technicians.

Additional Information:

Pennsylvania Patient Safety Advisory. Physiologic Alarm Management. September 2011.
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2011/sep8(3)/Pages/105.aspx

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Communicating Risks and Benefits: An Evidence-Based User's Guide

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FDA Reports

Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money, and reputations. Communicating Risks and Benefits: An Evidence-Based User's Guide provides the scientific foundations for effective communication.

Additional Information:

FDA Website. Communicating Risks and Benefits: An Evidence-Based User's Guide. September 18, 2011.
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm

Communicating Risks and Benefits: An Evidence-Based User's Guide. PDF version document.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM268069.pdf

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HeartNet

Information about Medical Device Reclassification

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FDA Medical Devices Classification

As experience and knowledge about a device increase, the original classification can be adjusted via the process of reclassification. Changes in classification are based on FDA's receipt of new information about a device. FDA may, on its own, or in response to an outside petition, change a device's classification by regulation. If a determination is made to reclassify a device, FDA publishes a proposed rule to reclassify in the Federal Register which includes the scientific justification for reclassification and which affords a period for comment. Subsequently a final rule is published in the Federal Register which changes the reclassification.

Additional Information:

FDA Medical Devices Classification. Reclassification. February 8, 2011.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm080412.htm

Federal Register. Reclassification of the ECG Electrode. August 22, 2011.
http://www.gpo.gov/fdsys/pkg/FR-2011-07-21/html/2011-18391.htm

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HomeNet

Home - The Best Place for Healthcare

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The Joint Commission

Many agree that the home is the best setting for providing health care to increasing numbers of patients. Not only can care be provided less expensively in the home, evidence suggests that home care is a key step toward achieving optimal health outcomes for many patients. These studies show that home care interventions can improve quality of care and reduce hospitalizations due to chronic conditions or adverse events. The Joint Commission is working to further improve home care interventions by including the prevention of avoidable causes of hospital readmissions, such as medication errors and falls, in its Home Care National Patient Safety Goals.

Additional Information:

The Joint Commission. Home – The Best Place for Healthcare. A positioning statement from The Joint Commission.
http://www.jointcommission.org/home_%E2%80%93_the_best_place_for_health_care/

The Joint Commission. Home – The Best Place for Healthcare. April 12, 2011. PDF Version Document.

http://www.jointcommission.org/assets/1/18/Home_Care_position_paper_4_5_11.pdf

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KidNet

Pediatric Safety Website

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FDA Science and Research - Pediatrics

An FDA Resource for pediatric safety information related to drugs, biologics and medical devices.

Additional Information:

FDA Science and Research – Pediatrics. Pediatric Safety. March 3, 2010.
http://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/ucm106609.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 the period July 1 through July 31, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


CARDIOVASCULAR

Device:
Type: Angiography Pack
Manufacturer: DeRoyal
Brand: Angiography Pack
Lot #: 25081847
Cat #: 89-7387.01
Other #: REF 89-7387.01

Problem:
While the RN was setting up the sterile field for a cardiac procedure, she opened a Angiography pack. She noted a dead worm in the sterile kit. The sterile field was torn down and set up again. No patient contact as incident happened before patient brought into room.
======================
Manufacturer response for Angiography Pack, Angiography Pack (per site reporter)
======================
Customer Service Representative was notified of incident.
QFI #22061. The manufacturer will send a replacement kit. Worm will be sent to manufacturer for investigation. Picture of worm available. Worm sent to the manufacturer.


Device:
Type: Catheter, Ablation, Cryo, Cardiac
Manufacturer: Medtronic, Inc.
Brand: Arctic Front
Lot #: 61588

Problem:
The sensor reading of the catheter read the temperature was too high and that blood was present within the catheter. This reading was not accurate as the system was made air tight and closed. Several attempts were made to rectify the issue including changing connectors to the catheter, reflushing the catheter to remove all potential air bubbles and testing the catheter outside the body in water. The balloon was also inflated to attempt cryofreezing, but these attempts were also unsuccessful in resolving the temperature error. A new Arctic Front ablation catheter was used in order to complete the procedure. There was no known injury to the patient.

Device:
Type: Catheter, Continuous Flush
Manufacturer: Boston Scientific Corporation
Brand: Renegade
Model#: M001282880
Lot #: 14097058
Cat #: M001282880

Problem:
Neuro Renegade Hi-Flo catheter was advanced over a Synchro-2 guidewire into the intracranial portion of the left vertebral artery and positioned in the left posterior cerebral artery for a Neuroform EZ stent placement. Initially a Neuroform EZ was prepped, but could not be advanced through the catheter. This was removed. Another Neuroform EZ stent was prepped. Again, this one could not be advanced through the catheter. The Neuro Renegade catheter was removed and there appeared to be a defect (kink) in the piece near the hub of the catheter.


Device:
Type: Catheter, Mapping, Cardiac
Manufacturer: Biosense Webster
Brand: Lasso 2515 Nav
Lot #: 15400161L
Cat #: LN222515CT
Other #: 35U251R

Problem:
During a complex A-fib ablation procedure, while the physician was positioning the Lasso catheter from left to right side of heart when the catheter became entangled in the tricuspid valve. Multiple attempts to remove the catheter were unsuccessful, the physician met resistance when trying to remove the catheter. The cardiovascular (CV) surgeon was called; a bedside 3D echo was performed. Per the surgeon's suggestion, the catheter was removed under echo guidance. Once removed, there was evidence of tissue on the tip of the catheter which was sent to pathology and identified as tricuspid valve tissue. There was no visible defect noted on the catheter itself. The patient was transferred to CICU. The patient was unable to go to surgery a week later, due to low platelet count. The patient requires an ablation, repair of shunt and tricuspid valve. The patient is currently on oxygen, is awake, and talking.


Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow
Brand: Pressure Injectable Multi-lumen Cvc Kit
Model#: CDC-45703-XP1A
Lot #: RF1046257

Problem:
Patient with 35% total body surface burns on chest was undergoing line changes every three days. As the resident started to place the wire, it fractured and started to unravel underneath the patient's clavicle. The incision had to be extended in order to remove the wire. Other than the cut down, the patient had no other sequela from this incident.
======================
Manufacturer response for CVC Kit, Pressure Injectable Multi-Lumen CVC kit (per site reporter)
======================
Lot pulled from Central Distribution and units. According to an email received from the firm: "We went to the SICU and Burn unit to look for the lot number in question. No kits on either unit were found. We were able to find one case in CD. Arrow has issued a credit for return. We will send the UF another case to replace the lot number in question. UF uses 3600 triple lumen kits. UF has reported having 4 spring wire-guides (SWG) unravel within the last month. This is a less then 1% occurrence throughout the year. Based on that information it was most likely a bad lot of kits. The numbers also show that it is not a technique issue. If there are any other SWG issues please have the units keep the product as well as lid-stock."


Device:
Type: Catheter, Swan Ganz
Manufacturer: EDWARDS LIFESCIENCES, LLC.
Brand: Venous Infusion Port (Vip) Five Lumen
Model#: 831HF75
Lot #: 58971113

Problem:
The patient's Swan Ganz was attached to the GE Marquette monitor. The temperature reading was 104.0 degrees. When the temperature was taken temporally it registered at 98.2 degrees. All cables were changed and the module. This did not change the results. The patient was afebrile. Biomed was called in and the monitor was checked as well as modules and all cables involved. Equipment and cables were found to be in working order.
======================
Manufacturer response for Thermodilution Venous Infusion Port (VIP)Swan Ganz, Swan Ganz (per site reporter)
======================
Edwards Lifesciences is sending return box to hospital to have product returned to them.


Device:
Type: Compressor, Cardiac, External
Manufacturer: Physio-Control
Brand: Lucas 2
Model#: 100250-00

Problem:
An ICU patient in cardiac arrest had the LUCAS device applied for chest compressions per manufacturer's directions. It worked for approximately 2-3 minutes then stopped working. There was an audible alarm and the alarm button and 3rd battery indicator light turned red. The device turned off and then back on but continued to alarm and would not restart. The device was removed; manual compressions were restarted until a different device was available. When the audible alarm went off and the alarm light and 3rd battery indicator light turned red, the first 2 battery indicator bars stayed lit in green. The battery on this device is checked nightly to assure full charge at all times.
======================
Manufacturer response for LUCAS 2 Chest Compression Device, LUCAS 2 (per site reporter)
======================
"For the symptoms described, the technicians suggested to check for broken/smashed wires from the hood pressing down on them and the sharp edges of the boards. This has been known to cause these symptoms" - direct quote from sales rep e-mail to our BioMed dept. We have asked for loaners to replace so they can check these machines out themselves as this problem occurred in earlier this year as well.


Device 1:
Type: Defibrillator, Crt
Manufacturer: St Jude Medical
Brand: Unify
Model#: CD3231-40

Device 2:
Type: Lead, Defibrillation
Manufacturer: St. Jude Medical
Brand: Durata
Model#: 7120

Device 3:
Type: Lead, Left Ventricular
Manufacturer: St Jude Medical
Brand: Quickflex
Model#: 1258T/86

Device 4:
Type: Lead, Pacemaker
Manufacturer: St. Jude Medical
Brand: Optisense
Model#: 1699TC/46

Problem:
Patient with a history of nonischemic cardiomyopathy, left bundle-branch block who underwent implantation of a St. Jude biventricular ICD system which was complicated by lead dislodgement and pericardial effusion requiring pericardiocentesis as well as requiring extraction of all the leads and the pre-implantation of all the leads 3 days later along with the bi-ventricular ICD. There was improper pacing noted when the device was tested. Device programmer displayed error message ("atypical response"). The patient was admitted to the CCU and Medicine Cardiology Service on the day after the implant following hypotension and new-onset atrial fibrillation in setting of bi-ventricular ICD placement with RV lead displacement. Bedside echo revealed pericardial effusion, and given suspected tamponade physiology, patient was taken for urgent pericardiocentesis. The pericardiocentesis resulted in 180cc bloody fluid removal, and a pericardial drain was placed. The patient returned to the CCU for furthering monitoring. Upon return, the patient remained in atrial fibrillation with rapid ventricular response (HR 150s), thus was loaded with amiodarone and continued on an amiodarone drip. Later that evening, the patient was again noted to become hypotensive, with systolic blood pressures (SBP) 60s, although she remained asymptomatic throughout.

Two days after this episode, the patient returned to the EP suite for revision of the right ventricular (RV) lead. Extraction of right atrial (RA) lead, RV lead, and left ventricular (LV) lead was performed, with subsequent implantation of atrio-biventricular ICD system in the left pre-pectoral position. The pericardial drain remained in place, with close monitoring of output following. Patient remained hemodynamically stable, and was transferred to floor status the next day. The pulmonary artery (PA) catheter was subsequently removed. The patient was seen in clinic on over two weeks later, at that time, patient was feeling great.


Device:
Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Mrx
Model#: M3535A

Problem:
The unit (defibrillator) failed a self-initiated auto test which resulted in a functional lock-out and audible alarm occurring at 00:37am. The staff was not aware of the issue until 11:00am when they investigated the beeping alarm (the unit was in an E.P. Lab not in use that day). The unit (defibrillator) displayed a message: "Charge Shock Failure - Therapy PCA".

Biomed response was to verify the problem [running unit's (defibrillator) OpCheck (operational check/test) function did not clear symptom] and removal of the unit to Biomed. The battery was removed to silence the alarm. The symptom was observed multiple times in Biomed during the OpCheck function. The manufacturer was called and while on the phone they asked for the serial number [which is under a removable AC power supply]. After the AC power supply was reattached and an OpCheck performed the symptom cleared. We believe that a total power down reset occurred because the battery was still removed when the AC supply was removed. Not explained was the fact that the symptom persisted even after the unit was transported to Biomed with the battery removed and no AC power connected. The symptom cleared only after both the battery and the AC power supply was removed, followed by the OpCheck routine.

This unit was returned to the manufacturer for evaluation and their findings are not known at this time.


Device:
Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A

Problem:
During a code blue the patient went into asystole, transcutanious pacing was started with success. The patient was intubated and regained a pulse with 100% pacing. While preparing to transport the patient to CCU, defibrillator was unplugged and moved off of the code cart to the bed. When the defibrillator was moved off of the code cart the battery came out of defibrillator and turned off the entire defibrillator. The battery eject button was accidently pushed in by the lip on top of code cart while defibrillator was being removed. The patient lost pacing and went back into asystole. The battery was shoved back into the defibrillator, the external pacemaker turned back on and the settings were restored with success of patient capture and resumed pacing the patient.

Over two years ago we contacted the manufacturer about this issue happening several times to us. They did not have a way to cover or protect the battery release button from accidently being activated. We ended up attaching material (plastic) to the bottom of the defibrillator to raise it up enough so the release button would be higher then the lip of the code cart.


Device:
Type: Hose, Nibp Adapter
Manufacturer: GE Healthcare
Brand: Critikon
Model#: 330062
Cat #: 330062

Problem:
The NIBP machine from a nursing unit was not working. The NIBP device was tagged and sent to biomed. The biomed technician called me to alert me to his findings. He stated that the entire NIBP tubing was filled with blood. We could not identify when this machine was taken out of service, which patient it was last used for and the staff member that used it prior to the dysfunction. There is concern that this product/device (NIBP hose adapter) fits our IV tubing connections. It does not have a unique fitting in order to prevent someone a
ccidentally attaching it to IV tubing.

When this event was brought to my attention, I removed an IV cap from an IV tubing injection site and was able to connect the GE/Critikon NIBP male slip Luer connector from the cuff adaptor to the injection site.

We do not know if this one was actually ever connected to the IV tubing; however we did discover that it was possible, which is a concern.


Device:
Type: Lead, Defibrillation
Manufacturer: St Jude Medical Cardiac Rhythm Management Division
Brand: Durata
Model#: 7120Q/58

Problem:
Primary prevention patient had ICD system implanted. The procedure was uneventful, post procedure stay uneventful, and was discharged to home the next day. The patient returned to the ED in the evening on the day of discharge. A lead perforation of the right ventricle was seen on CT scan. The next day, the patient was transferred to another facility for lead extraction with the procedure performed the following day. At that time a new lead was implanted.


Device:
Type: Monitor, Physiological, Transport
Manufacturer: GE Healthcare
Brand: Transport Pro
Model#: Transport Pro

Problem:
Team was transferring the patient from the Interventional Radiology (IR) table to the radiant warmer. The IR RN was moving the transport monitor to the patient's bed. The Tram housing (Tram chute) fell off the monitor (Transport Pro) and landed on patient's arm and chest. We have four of these type devices (monitors). We found 1 with a missing screw (that locks the Tram housing to the monitor) in April. Then we had this reported incident. Upon inspection of the remaining 2, we found that both had loose screws that were near to falling out. The Tram housing on our four Transport Pro monitors have been secured with a screw and locking nut until GE is notified and responds with an official modification.


Device:
Type: Pump, Intra-aortic Balloon, Air Transport
Manufacturer: Arrow International, Inc.
Brand: Autocat2
Model#: Autocat2

Problem:
This incident concerns equipment malfunction during a Survival Flight patient transport. The incident occurred at the bedside in the Cardiac/surgical ICU at an Out Side Hospital. The patient had an Intra-Aortic Balloon Pump (IABP) in place. The patient had been successfully transitioned from the unit's IABP to the transport IABP. It had been running normally for approximately 90 minutes when the display screen went blank on the transport IABP. Shortly after, a burning odor was noticed. The lower right part of the screen became warm to the touch and began to discolor. The screen was then unplugged. The IABP continued to pump. The patient was placed back on the home unit IABP. A second IABP was flown from our hospital. The patient was placed on the replacement transport IABP successfully, and the transport was completed to the hospital. At no time did the patient have a drop in blood pressure or cardiac output. There is no service bulletin from Arrow; they issued a Tech Tip "Display Head Locknut Improvement" document. I think this should be a corrective action.


GENERAL & PLASTIC SURGERY

Device:
Type: Cap, Surgical
Manufacturer: Medline
Brand: Pro Series
Lot #: 1005121063
Cat #: NON28233B

Problem:
Surgical technician noted that the surgical caps, "bouffant caps" were a much darker color than usual when the was box opened. The technician noted that the left side of her hairline was red "like a burn". She was sent to employee health for follow up.


Device:
Type: Endowrist Instrument Needle Driver
Manufacturer: Intuitive Surgical, Inc.
Brand: Mega Needle Driver For Davinci System
Model#: 420194
Lot #: VER-05 1301 071 943
Cat #: 420194
Other #: 8mm

Problem:
Operating staff report that while surgeon was utilizing an 8mm Mega Needle Driver in a robotic assisted surgery one of the cables broke. The cable evidently moves the tip of the device when handpiece is triggered (moved). You can visualize the cable sticking out the tip of the device. The device is evidently meant to have "10 lives". After each case the device is sent to our Sterile Processing Department and re-used until the 10 uses have expired. The device in question was on its 10th use. No injury to patient; surgeon confident no pieces of the cable entered the surgical site. Device sequestered and removed from field. New device of same type/model obtained and used to complete the case with no further issues.


Device:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate
Model#: PXR35
Lot #: H4375P
Cat #: PXR35

Problem:
Closing skin after a C-section and the stapler kept making a click noise and the staples would come out straight and not curve around in the skin. Seven total staplers opened before skin was closed.


Device:
Type: Surgical Drape
Manufacturer: Cardinal
Brand: Surgical Drape
Cat #: 3/4 sheet, split sheet

Problem:
Doctor was using the tps burr (6.5 ) After use it was put down on the drapes, and it melted a hole through the top 2 drapes. This happened again after using the burr. The drape was covered with sterile ioban. After the case the affected portion of the drape was removed and sent to biomed. The tps automatically sets the speed for the burr.

See device images:

image shows a hole on a surgical drape; hole is approximately a centimeter wide and resulted after a tps burr made contact with the surgical drape

close up image showing a hole on a surgical drape

image shows a hole on a surgical drape and a ruler to the right of the hole.  Ruler indicates the size of the hole is approximately a centimeter in size

 image shows a hole on a surgical drape and a ruler to the right of the hole.  Ruler indicates the size of the hole is approximately a centimeter in size


Device:
Type: Surgical, Razor
Manufacturer: Medline
Cat #: PMM# 9893 DYND70845
Other #: Handle/Head

Problem:
There are four written reports and several verbal reports that indicate when using clippers prior to procedures, abrasions, scratches, and nicks were found on the patient after use of the clipper. This product has been used at this facility for approximately three years. This issue just started to occur in the spring of this year according to my knowledge. There is no large turnover of staff.


Device 1:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: DC5393
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Device 2:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: CK6808
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Device 3:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: CK6808
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Problem:
During an eye strabismus surgery a 6-0 Vicryl suture was used and began to fray in several areas along the suture.

A second procedure was scheduled same day with a new patient. The OR nurse obtained the same 6-0 Vicryl sutures but from a different lot than the first failure and the same fraying occurred. The physician did continue to use the frayed suture once started in both of these cases.

In a third case, same day, same procedure, the 6-0 Vicryl suture package was opened from sterile packaging for use. The physician noted at that time the suture was frayed. This suture was not used and retained.

All remaining boxes from both lots have been removed from OR stock to be returned to manufacturer.

Manufacturer response for Suture, Absorbable, Coated Vicryl, (per site reporter): Vendor representative contacted by Materials Management. All unopened boxes from both lots to be returned and replaced with new.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Cook Medical
Brand: Cook Medical
Model#: G50740
Lot #: 2663751
Cat #: G50740
Other #: UPICS 5.0 CT ABRM

Problem:
During insertion of PICC catheter, Physicians Assistant (PA) was withdrawing the guide wire and the distal tip broke off and was retained in the patient's arm.


Device:
Type: Catheter, PICC
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Brand: L-cath PICC
Lot #: 384539

Problem:
PICC was life line to patient. The catheter was removed in its entirety without any dislodgement to the heart or pulmonary vasculature. The added radiation absorbed dose (RAD) exposure was twenty minutes. At twenty minutes physician and team had a small fragment dangling in the femoral vein out of reach surgically. The consequences of the piece embolizing to the heart or more dreadful to the pulmonary vasculate could be huge. The team was close to removing the fragment via IR and physician felt it was the best and safest procedure with more RADS. Indeed the decision paid off as the fragment was retrieved. Total RAD was twenty-two minutes. More info: L-Cath PICC essentially fell apart and required interventional radiology to remove the intra-abdominal intravascular portion of the catheter. Physician had to surgically remove fractured fragments from the leg veins. Patient's vein had created a fibrin sheath around the catheter causing it to be stuck within the vein.


Device:
Type: Catheter, PICC
Manufacturer: Bard Access System, Inc.
Model#: 5FR DL MB INT TRAY W/SHERLOCK & SAPIENS
Lot #: LOT REVA1234/REVB0941
Cat #: 1275108D
Other #: REF# 331968

Problem:
In the morning, the PICC Nurse was removing the guide wire from a newly placed PICC catheter. The PICC catheter bunched up and split during the removal. The catheter was immediately removed and pressure held. There was no harm to the patient.


Device:
Type: Catheter, PICC, Introducer
Manufacturer: Bard Access Systems
Brand: Microez Introducer
Model#: 0678935
Lot #: REVC0022
Cat #: 0678935

Problem:
RN attempted peripherally inserted central catheter (PICC) line in patient's left upper arm. Vein successfully cannulated using guided ultrasound and then guide wire was introduced. Micro-Introducer then was placed over guide wire without complications to secure location within vessel. Good blood return coming from outer open edge of the micro-introducer. Upon trying to pull inner cannula (dilator) out of the micro-introducer, the guide wire began to shred. Procedure immediately stopped and MD notified. Upper arm x-ray taken to visualize wire location and RN held guide wire securely until assessed by pediatric surgeon. Wire successfully removed by surgeon and pressure dressing placed over site.


Device:
Type: Catheter, Picc, Introducer
Manufacturer: Vygon
Brand: Nutriline -Catheter With Splitting Needle
Model#: ref 1252.30
Lot #: 042494

Lollipop Icon

Problem:
While RN inserting PICC line, the PICC line introducer's splitting needle broke at wings leaving needle on the catheter. RN unable to remove needle from catheter so line had to be pulled and infant re-stuck for line.


Device:
Type: Catheter, Umbilical Artery
Manufacturer: Covidien
Brand: Polyurethane Umbilical Vessel Catheter With Luer Lock Hub
Cat #: 8888 160333

Lollipop Icon

Problem:
After accessing umbilical artery catheter (UAC) with stop-cocks closed and all connections tight, blood was flowing back quickly from baby. When investigated, a split was found in UAC below hub. The UAC was clamped and MD notified. UAC was eventually removed. There was no apparent injury. Blood accessed by drawing labs via venipuncture or heel stick.


NEUROLOGY

Device:
Type: Holder, Head, Neurosurgical (Skull Clamp)
Manufacturer: CAREFUSION 2200, INC.
Brand: Spetzler

Problem:
Event involved skull head holder and base unit. Patient had cervical stenosis. Patient was scheduled for C5-6 laminectomy, left C5-6 and left C6-7 foraminotomies. During pre-operative safety check equipment found to be functioning properly. When positioning the patient the head holder malfunctioned and the case was aborted.


Device:
Type: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Manufacturer: Advanced Neuromodulation Systems Inc.
Brand: Eon Mini
Model#: 3788

Problem:
Patient had a successful implantation of ANS Neurostim Spinal Cord Stimulator (SCS) ~3 years ago. This SCS was noted to have a failure after 2 years of implantation. Patient returned to surgery recently for replacement of SCS generator.

Recall online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94501


ORTHOPEDIC

Device:
Type: Bone Graft
Manufacturer: Medtronic
Brand: Infuse
Lot #: M111057AAD
Cat #: 7510200

Problem:
Sterility associated with BMP-2. Inflammatory reaction occurred that injured superior hypogastric plexus.



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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem Gastrointestinal Tubing and Accessories

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Gastrointestinal tubes and accessories are devices consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting or suppressing bleeding of the alimentary tract. These devices may incorporate an integral inflatable balloon for retention or hemostasis (1).

Over the past year, MedSun has received 22 adverse event reports associated with the use of gastrointestinal tubing and accessories (enteral feeding tube devices) manufactured by 6 firms. The firms are Acacia, Bard, Boston Scientific, Corpak Medsystems, Kimberly-Clark, and Vygon. The reports were submitted by 18 MedSun hospitals between August 2010 and August 2011.

The device problems reported included leak, ruptures, misconnections, and other device failures. When these failures occur, the patient often requires an additional medical or surgical procedure to continue therapy. These device failures may also cause pain and discomfort to the patient. Additionally, the patient would have a delay in feeding or altered nutrition. The reported enteral tube problems are shown below:

• Balloon broken/ruptured - 5
• Leaking tube connection - 3
• Tube dislodged – 3
• Tube misconnection - 3
• Balloon leak - 1
• Unable to remove Stylet - 1
• Incorrect tube placement - 1
• Tube discoloration - 1
• Unable to place tube - 1
• Dislodged cuff - 1
• Tube disconnection from patient - 1
• Tube torn - 1

There were no reported patient deaths in these reports. There were 5 instances of patient injuries listed in the 16 reports. The reported injuries are listed below:

• Procedure required to replace tube - 3
• Incorrect tube placement - 1
• Surgery required to replace tube - 1

Of the reports that listed patient age, 10 had a patient age listed as less than 21 years and 6 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 9 reports involved male patients.

The MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with gastrointestinal tubing and accessories from the last two years. MedSun reports may or may not be involved in the recall(s) listed.

Recall Number: Z-1203-2010
Date Posted: 03/24/2010
Product: Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2
Code Information: 1015.062M Vygon/Churchill Medical System
Recalling Firm/Manufacturer: Churchill Medical Systems, Inc.; 87 Venture Drive; Dover, New Hampshire 03820-5914
Action: Churchill Medical issued an Urgent: Product Advisory Customer Notification on January 29, 2010 to customers and distributors via overnight delivery. The letter identified the affected product along with the corresponding lot numbers and explained the problem. Accounts are requested to complete the enclosed form and fax it to 215-672-6740, attention Marie Benson. The affected products should be quarantined and customer service should be contacted to arrange return of product. Questions should be directed to Marie Benson at 800-473-5414.
Distribution: Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
Online Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=88562

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Kimberly-Clark, Mic-Key button gastrostomy tube NA, NA, AA0025F02 The balloon on the Mic-Key button gastrostomy tube popped out at home. The tube had been placed four months ago. The pt was brought to the ED where the tube was replaced without difficulty. A contrast study revealed good placement and the pt was discharged to home.
Kimberly-Clark, Jejunal Transgastric Feeding Tube NA, 0260-18, NA There was a possible aspiration episode due to the tube feeding being connected to the wrong port. The Gastric feeding tube had three ports. A Bronchoscopy was negative for aspiration, it showed a mucus plug. This was an isolated event.The pt had a mucous plug.
Vygon, Eight French Nutrisafe 2 361.082, VYGONBX50, e 150307FB or 13 The feeding tube came apart from hub when removing extension tubing. It did not impose a safety threat to one of the babies, but other breaks could. An analysis of device will be done. The tube was visually inspected prior to use.
Corpak, Corflo ultra pedi - enteral feeding tube NA, 20-8366, 42589 A six french nasogastric (NG) tube was inserted through patient's nosrtil. When the nurse was checking placement by auscultation, she noted that air was leaking through tube. The NG was taken out and a tear was noted in the NG tube.
Vygon, 60'enteral set with oral syringe adapter AMS-934-1, NA, 1006193 The leaks are occurring at the distal end where the syringe is attached to the tubing. Three separate tubing sets had leaks in same location. All were from the same lot.
Kimberly-Clark, Mic-Key
Mic-Key, NA, NA Seven months ago, the pt was admitted to our facility with a Prepyloric Channel Ulcer type three. The pt underwent a Truncal Vagotomy, Amtrectomy with Bilroth II and a Jejunostomy feeding tube placement. Last month, the pt developed a chronic fisutla of the left anterior abdominal wall. The pt underwent sugery for excision of the fisutla which revealed a foreign body in the fistula tract. The foreign body appeared to be the cuff from the Jejunostomy tube that was previously removed six months ago. The cuff was found to have contributed to the fistula. The cuff was removed in its entirety. The healthcare professional's impression is that the retained cuff from the Jejunostomy tube caused the fisutla.
Vygon, Enteral Feeding Set NA, AMS-372, 1006013 Patient's feeding tube was connected to the peripheral IV instead of the gavage tube. This was a medical misconnection: the enteral feeing tube was compatible with Luer-lock/PIV connector.
CORPAK MedSystems, Extension tubing NA, NA, NA The tubing attachment from the Corpac extension set was added to the new setup. The site was found to be leaking at the change of shift onto the bed linen that had been changed fifteen minutes prior. New tubing was placed. The tubing was found leaking and broke off inside the Jejunal (J)-tube. We were able to pull the broken part out of the J area.
Kimberly Clark UNIBODY GASTROJEJUNAL FEEDING BUTTON, 0270-16-2.5-45, AA0186N10 The pt was scheduled for a gastro-jejunal (GJ) tube change. The caregivers noted that the GJ balloon was not holding any water. Upon further assessment, the GJ tube was noted to be perforated. A snare was utilized to remove it. The Unibody GJ feeding tube was fractured. The distal end had to be retrieved in the jejunem. A new 16FR, 2.5cm stoma length, 45cm Jejunal length GJ feeding button was placed. There was no harm to the pt noted in the documentation.
Kimberly-Clark, MIC-KEY Low Profile Gastrostomy Feeding Tube MIC-KEY, 0120-14-1.7, NA The Nurse administered the tube feeding through the luer lock port. This port is for the balloon that keeps the feeding tube in place. This caused the balloon to rupture, requiring insertion of a replacement tube. This is not the first time this has happened. While we understand the need to do inservices on proper use, different nurses have misidentified and used the balloon port. This has occurred with feedings and/or medications instead of the correct port being used. It is felt that the device could be better labeled. Nurses are mistaking the balloon port as the feeding port. It has now happened more than once. It could be better labeled for those who may not be as familiar with the product in order to prevent similar events.
Kimberly Clark, MIC-KEY Low Profile Gastrostomy Feeding Tube MIC-KEY, NA, NA The medication was instilled into the pt's "Mickey" gastric tube balloon port causing the balloon to fracture. The balloon port was thought to be a medication port. The pt required the insertion of a new tube. The balloon port is not well identified and the staff used the balloon port thinking it was a feeding port. This caused the balloon to break, which causes a need for re-insertion.
Vygon, Six French feeding tube L.75cm ORX-XRO-XRC-PVC feeding tube, NA, NA The RN was attempting to place a six french percutaneous endoscopic (PE) tube for Go Lytely administration for a Bowel Prep with help from a second RN. The RN measured the tube for proper placement, lubricated the tip, and attempted to pass the tube via the right nostril. The RN met with resistance and removed the tube. Upon the tube's removal, the RN's noted small amount of bright red blood in the tube and around the nare. The RN's also noted the tip of the PE tube was no longer present. Approximately one mm of the tip of the PE tube was gone. The pt remained pink, warm and well perfused throughout and after the procedure. The MD was notified. The CXR that was ordered was clear.
Kimberly Clark, Gastrostomy Feeding Tube 12Fr 2.0 cm, 0120-12-2.0, AAO165F02 A premature male infant pt was admitted to the pediatric floor from the OR following an initial gastrostomy (GT)insertion. The pt arrived to the floor in the afternoon. Upon obtaining vital signs (VS) and settling the pt in, the GT was noted to have fallen out and was lying on the bed. The (GT balloon was tested by inflating the balloon and was noted to be leaking). A Foley was ordered to be placed into the stoma site and the pt was taken back to surgery about two hours later for replacement of the GT.
Boston Scientific, Enteral Feeding Tube 6672, NA, NA The pt's spouse is concerned about the pt's percutaneous endoscopic gastrostomy (peg) tube turning black. This peg tube is the second one where this has happened. The pt's spouse has contacted the Dr concerning this manner. The Dr is in contact with another physician concerning this matter. The company is Boston Scientific reference# 6672.
Kimberly-Clark, Mic*Transgastric-Jejunal 15 Fr 45 cm 7-10 ml, 0260-16, AA0102N08 The pt had a gastro-jejunal (GJ) tube replaced last month as her other one had partially come out. The pt returned because the new GJ tube had fallen completely out. They brought the tube in with them and the balloon had burst.
CORPAK MedSystems, CORFLO, ULTRA LITE feeding Tube NA, 20-9551, NA Post placement of a Corpak enteral feeding tube, the x-ray was read by radiologist. The Radiologist notified the nursing staff that the Corpak tube was noted to be in the pt's lung and the pt had a pneumothorax. The Corpak tube was removed and the chest tube was placed by the MD and the pt was chemically paralyzed.
Bard Access Systems, Gastric Decompression Jejunal Feeding Tube 9 French, NA, NA The pt had a percutaneous endoscopic gastrostomy tube (PEG) and received tube feedings but was having high gastric residuals. A Bard jejunal extension feeding tube was placed through the PEG tube to allow post pyloric feeds. High gastric residuals continued and it was noted that the jejunal feeding and gastric suction port of her tube were not being utilized properly. The tube feeding was connected to the suction port rather than the feeding port. The design of the port labeling is difficult to read as the raised letters are small and the same color as the blue tube end and blend in with the tube. Link to the Bard catalog – see page 4. http://www.bardaccess.com/assets/pdfs/other/MC-0029-02_Enteral_Feeding_Tube_Catalog_web.pdf. We have a close up picture of the ports that we can send to MedSun. Availability of device: Device continues to be used in the pt for tube feeding.
CORPAK MedSystems, Cortrak Feeding Tube with Stylet Model# 10 French, 20-9431TRAK, NA The RN reported that they placed a Cortrak device in the pt but were then unable to remove the stylet. The cortrac was removed and new one was placed without incidence.
Kimberly-Clark
Twelve French MIC-KEY Button
12 French, NA, NA During the pt's assessment it was noted that the infant was agitated and pushed against the gastrostomy tube (GT). Mittens were intact on the pt's hands. The pt had pushed against the tubing with an arm and the GT came out of the surgical site. Upon examination, it was noted that the balloon was broken and not intact. The continuous feedings were stopped. A new device was inserted and feedings were restarted.
Kimberly-Clark, Mic-Key* Low-Profile Gastrostomy Feeding Tube NA, 0120-16-1, AA0333F08 A pt was in the pediatric ICU (PICU) for procedural sedation for the placement of a 16 French Mic-Key button and the removal of an existing gastric jejunal (G-J) tube. The pt was G-tube dependent secondary to severe reflux. The pt was sedated with Propofol. The G-tube the pt's family brought with them from the physician's office had a leak in the balloon and was unusable. A 14 French Mic-Key button was used in its place. There were two failed attempts before the third placement was successful.
Kimberly-Clark, MIC NA, 0100-22, AA1059D05 The staff noticed the gastrostomy feeding tube coming out of the pt as numbers were now visible on the tubing. The Surgeon checked the tube and indicated it was dislodged and removed the tube. The balloon was felt to be deflated in error due to unfamiliarity with the device. The pt went to Radiology for injection of the sinus tract for the reinsertion of a new tube that was unsuccessful. The pt was changed to parenteral nutrition until they could return to surgery four days later for a new tube replacement.
Acacia, Inc., Enteral Feeding Tube, 6.5 Fr, 36" NA, ENPV-36-65, A6089 The feeding solution was observed leaking from the connection. The nurse discovered a crack in the connector of the feeding tube. The feeding tube was replaced and the old one was discarded. No significant consequences to pt.

Additional Information:

1. Code of Federal Regulations, “Gastrointestinal Tube and Accessories”. 21 CFR 876.5980 (2010).

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Updated October 1, 2011

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