MedSun's KidNet Promotes Neonatal and Pediatric Patient Safety
MedSun: Newsletter #47, April 2010

By: Suzanne Rich, RN, MA, CT
MedSun/OSB Division of Safety Partnerships

KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

Currently, 42 MedSun hospitals are participating in KidNet. Just over half of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. We launched KidNet in June 2007. Although the focus of KidNet is on device-related adverse events occurring in the NICU or PICU, reports of events occurring in other areas of the hospital involving neonatal or pediatric patients are both welcome and encouraged.

For calendar year 2009, MedSun received 147 reports involving pediatric patients (those with ages listed as less than 21 years) from all clinical areas in MedSun KidNet hospitals. Of these, 62 reports were marked as KidNet or the event location was marked as NICU, PICU, or critical care. The data discussed in this article are derived from these 62 reports.

This bar graph illustrates the number of KidNet reports received by quarter. These reports were submitted by KidNet participant sites over the 2009 calendar year. The 62 KidNet reports have been grouped by quarter (1st quarter, 2nd quarter, 3rd quarter, 4th quarter). The x-axis corresponds to quarter; the y-axis corresponds to the number of reports. Left to right description of image: of the 62 KidNet reports received in 2009, the light purple data point shows that 28 KidNet reports were received in the 1st quarter. The burgundy data point shows that 17 KidNet reports were received in the 2nd quarter. The yellow data point shows that 23 KidNet reports were received in the 3rd quarter. The tallest data point, depicted by a light blue bar shows that 14 KidNet reports were received in the 4th quarter.
*Figure 1: 2009 KidNet reports by quarter

As part of the larger MedSun network, KidNet emphasizes the importance of recognizing and reporting device related adverse events associated with patient, family member, or healthcare provider death or serious injury, and in recognizing and reporting problems representing ‘potential for harm’ and ‘close call’ events. The majority of reports from KidNet in 2009 involve device-related problems described as minor harm, potential for patient harm, or close call events. Three reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury), and one report is associated with a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2009. The 62 reports are categorized by event type, specifically by the categories of: product problems, serious injury, and death. Of the 62 reports, 58 reports were submitted as product problems, depicted by a light purple pie wedge. 3 reports were submitted as serious injury and 1 report was submitted as death, which is depicted by burgundy and yellow pie wedges, respectively.
*Figure 2: 2009 KidNet reports by event type

The three reports describing serious injury events (those requiring medical or surgical intervention taken to prevent permanent impairment or damage) involve an umbilical vein catheter, a drug wound dressing, and an oxygenator used in extracorporeal membrane oxygenation (ECMO). The event involving a leaking umbilical vein catheter describes the catheter snapping when it was removed by a healthcare provider, which requiring intervention to remove the retained device. The event with a drug wound dressing involves an infant with a tracheotomy who experienced increasing respiratory distress. Emergent removal of the tracheotomy device plug at the bedside with anesthesiology present resulted in the identification and removal of absorbable dressing found within and around the tracheotomy stoma resulting in immediate improvement of symptoms. The event associated with a membrane oxygenator involves a patient experiencing severe hypotension after being placed on ECMO when the temperature probe port on the top of the membrane oxygenator of the ECMO circuit fractured with blood escaping from the circuit. Manual resuscitation and ventilation including cardiac massage was undertaken until the membrane oxygenator could be replaced, the ECMO circuit restarted, and patient transfer to PICU was accomplished.

The event associated with a patient death involves a patient initially admitted for low intracranial pressure (ICP) and headaches who went to the operating room for insertion of a parenchymal bolt intracranial monitoring device. After receiving medication for pain, the patient became apneic and stopped breathing with pupils becoming fixed and dilated. The patient was intubated and the intracranial monitoring device was checked and adjusted. Upon confirmation of proper placement, the subsequent intracranial pressure reading was high. Despite extensive brain resuscitation, the patient’s parents requested that care be withdrawn, and the patient died.

The 62 KidNet reports reference 66 devices, of which there are 31 different types. The number of devices is greater than the number of reports as more than one device may be referenced in a report. The 31 reported device types have been grouped by clinical medical specialty as defined in the listing below for the chart that follows.

(1) IV devices – PICCS, ports, central venous catheters, umbilical catheters, IV tubing, pumps

(2) AN/Respiratory products – anesthesia mixers, ventilators, ventilator tubing, oximeters, respiratory humidifiers, and tracheotomy tubes

(3) CV/Neurology devices - EKG electrodes, cardiopulmonary bypass devices, blood pressure monitor transducers, external pacemakers, intracranial pressure monitors

(4) GI/GU products – enteral infusion pumps, feeding tubes, urethral catheters, urine collectors

(5) All others - thermometers, illuminators, over the counter blood glucose monitors, drug wound dressings, circumcision clamps

This bar graph illustrates the number of reported medical devices by type in 2009 KidNet reports. The 66 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to type of device; the y-axis corresponds to the number of devices reported. Left to right description of image: of the 66 devices reported in 2009, the tallest data point, depicted by a light purple bar, shows that 26 reports involve Intravenous (IV) devices. The burgundy data point shows that 19 reports involve Anesthesiology/Respiratory devices. The yellow data point shows that 9 reports involve Cardiovascular/Neurology devices. The light blue data point shows that 6 reports involve Gastroenterology/urology devices. The dark purple data point shows that 6 reports involve All Other device types.
*Figure 3: 2009 KidNet reported devices by type

Reported patient demographics include patient age and gender, both of which were provided in 47 of the 62 reports. There are almost twice as many reports involving females than males.

This pie chart illustrates the number of 2009 KidNet reports that specify patient gender. The 47 reports are categorized by gender, specifically by male and female. Of the 47 reports, 17 reports involving male patients were submitted, which are depicted by a light purple pie wedge. 30 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.
*Figure 4: 2009 KidNet reports by patient gender

The patient ages provided in 47 of the 62 reports range from 2 days to 18 years with the majority of reported ages with patients less than 2 years old.

The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels at http://www.fda.gov/cdrh/ode/guidance/1208.html.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2009 KidNet reports. The 47 reported patient ages have been grouped by pediatric subpopulations. The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of patient ages reported. Left to right description of image: of the 47 reported patient ages in 2009, the light purple data point shows that 20 reports involve newborn patients (0-30 days). The tallest data point, depicted in burgundy, shows that 20 reports involve infant patients (30 days-2 years). The yellow data point shows that 5 reports involve child patients (2 years-12 years). The light blue data point shows that 2 reports involve adolescent patients (12-21 years).
*Figure 5: 2009 KidNet reported patient ages by pediatric subpopulation

Information on the device user at the time of the event was provided in 34 of the 62 KidNet reports with the nurse most frequently cited as the device user.

This pie chart illustrates the number of reports by device users - who was operating the device at the time of the event – in 2009 KidNet reports. Of the 62 KidNet 2009 reports, 34 reports indicate the device user. Of the 34 reports indicating device user in 2009, the largest segment, in light purple shows that 21 reports specify nurses were operating the reported device at the time of the event. The burgundy segment shows that 7 reports indicate that doctors were operating the reported device at the time of the event. The yellow data point shows that 6 reports identify other allied health providers as the user operating the reported device at the time of the event.
*Figure 6: 2009 KidNet reports by device user


The goals of KidNet are:

(1) to improve the recognition, reporting, and understanding of device-related adverse events occurring with pediatric patients, especially those in NICUs or PICUs, and (2) to develop a clinical community to amplify signals of actual or potential medical device problems affecting NICU or PICU patients recognized by FDA or KidNet participants to facilitate timely interventions to address actual and potential device-related problems during clinical use.

This concept is based on collaboration and communication between FDA, KidNet participants, and device manufacturers, in order to better understand device safety and to identify solution and prevention strategies to address identified problems.

To this end, KidNet sponsored a webcast entitled, Peripheral IV and PICC Safety in Pediatric and Neonatal Patients in November of 2009. The webcast, featuring a speaker specializing in pediatric intravenous therapy from a MedSun KidNet hospital, described complications associated with peripheral intravenous (IV) catheters and peripherally inserted central catheters (PICC) used in pediatric and neonatal infusion therapy. Additionally, the role of human factors in peripheral IV and PICC catheter adverse events was discussed with strategies identified to address device related complications involving peripheral IV and PICC catheters.

Presentation slides and audioconference transcripts are available for this webcast, online available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm206357.htm. Additional MedSun and KidNet programs are also available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112724.htm.

The following are 2 examples of neonatal and pediatric device-related problems reported through KidNet and MedSun in 2009 that represent just a few of the many successes from device-related problem recognition and reporting, information sharing, and solution strategy development by device users, FDA, and manufacturers working together to improve the safety of medical device use in neonatal and pediatric patients.

PICC Luer Hubs: Several reports were received from a MedSun KidNet site described events of cracking, leaking, breaks, and catheter occlusions related to cracking of luer hubs. The manufacturer had indicated that the problem was due to users over tightening the connections, a precaution listed in their instructions for use. MedSun follow-up with both the reporting site and the manufacturer prompted the firm to visit the site to better understand the reported events during clinical use. The manufacturer subsequently made materials and design changes in their product to address the reported events.

Infant Warmer: A report was received from a MedSun hospital involving a potential for harm event involving an infant warmer. Staff observed smoke and flame coming from the top of the warmer module cover while the unit was in the operating room pending delivery of an infant. The unit was in “pre-warm” mode but the infant was not in the bed. The biomed removed the top cover of the warmer module and observed one of the heater wires was detached. A manufacturer representative came to the facility to replace parts on the damaged unit and the heater elements on all of the other manufacturer’s units in the reporting facility. Follow-up with the manufacturer indicated changes were made to address the reported problem in both old and new units as part of a manufacturer recall.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of KidNet or MedSun, or through your hospital’s reporting policy. If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun