MedSun's KidNet Update: Continuing as a Model for Patient Safety
MedSun: Newsletter #71, April 2012

KidNet, launched in June 2007, 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, with an emphasis on those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

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 validate signals of actual or potential medical device problems affecting NICU or PICU patients. The goals are accomplished through collaboration and communication between FDA, KidNet participants, and device manufacturers.

Currently, 46 of the 350 MedSun nationwide network of hospitals are participating in KidNet. A little over one-third of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. The focus of KidNet is on medical device-related problems occurring in the NICU or PICU, which includes adverse events, ‘near-miss’ or ‘close-call’ events, and events representing ‘a potential for harm.’

From all hospitals participating in MedSun, we received a total of 634 reports involving pediatric patients (those with ages less than 21 years) in 2011. The number of reports received is up from a total of 556 pediatric reports in 2010.

Of these total 634 reports, 153 are from sites participating in KidNet; reports were received from 21 of the 46 KidNet hospitals in 2011. This represents an increase in the total number of KidNet reports received from 2010, which was 108. The data discussed in this article are derived from the 153 KidNet reports received in 2011.

This bar graph illustrates the number of KidNet reports received by quarter. These reports were submitted by KidNet participant sites over the 2011 calendar year. The 153 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 153 KidNet reports received in 2011, the light purple data point shows that 44 KidNet reports were received in the 1st quarter. The burgundy data point shows that 27 KidNet reports were received in the 2nd quarter. The yellow data point shows that 36 KidNet reports were received in the 3rd quarter. The tallest data point, depicted by a light blue bar shows that 46 KidNet reports were received in the 4th quarter.

We provided learning opportunities for MedSun KidNet hospitals through presentations via teleconferences and webcasts for healthcare professionals working in neonatal and pediatric patient care areas, focusing on the need to recognize and report device-related problems as part of their patient safety efforts. Additionally, in 2011, we increased the education and outreach to KidNet hospitals via telephone and e-mail. We believe this is a major factor in the increased number of reports received for 2011.

All but four of the 2011 reported events from KidNet involve device-related problems described as minor harm, potential for patient harm, or close call events. These types of reports demonstrate that our efforts to encourage the reporting of problems before a death or serious injury occurs have been successful. Three of the 153 reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury). One event in 2011 is associated with a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2011. The 153 reports are categorized by event type, specifically by the categories of: potential for harm, serious injury, and death. Of the 153 reports, 149 reports were submitted as potential for harm, depicted by a light purple pie wedge. 3 reports were submitted as serious injury and 1 report was submitted as death, which are depicted by burgundy and yellow pie wedges, respectively.

The three reports describing serious injury events (those requiring medical or surgical intervention taken to prevent permanent impairment or damage) involve IV products; two involve peripherally inserted central venous catheters (PICCs), and one event involves an IV connector. One event with a PICC catheter describes a complication of cardiac tamponade seven days after catheter insertion with recovery of infant’s heart rate immediately after emergency pericardiocentesis. The second event involves shredding of the guidewire when the inner cannula (dilator) was being pulled out of the PICC micro-introducer during insertion procedure. The wire was located via x-ray and then successfully removed by a pediatric surgeon. The third event involves a leaking IV connector whereby the patient did not receive the appropriate amount of medications resulting in a drop of blood pressure and blood sugar. The leaking connector was replaced and the patient’s blood pressure and blood sugar returned to normal values. The sole death report involves a rupture of extracorporeal membrane oxygenation tubing which caused the pump to stop.

In spite of being placed on emergency ventilator settings while the tubing was being replaced, the patient arrested and the patient’s cardiac function did not return.

The 153 KidNet reports reference 157 devices, of which there are 41 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 41 reported device types have been grouped into 6 clinical medical specialty areas as defined below for the chart that follows.

(1) IV devices –IV tubing, PICCs, infusion pumps, short term peripheral IV catheters, central venous catheters, implanted ports, fluid transfer sets, saline vascular access flush, infusion line filter

(2) AN/Respiratory devices – ventilators/high frequency ventilators, tracheostomy tubes and cuffs, oximeters, blood gas analyzer, nitric oxide delivery apparatus, bronchial tube, ventilator tubing, tracheobronchial suction catheter

(3) General Hospital devices - hypodermic needle, piston syringes, electronic thermometers, medical device disinfectants, skin pressure protector, pediatric bed, neonatal incubator, neonatal transport incubator

(4) GI/GU devices - gastrointestinal tubes, enteral feeding pumps, GU injectable bulking agents, implanted hemodialysis catheter

(5) CV/Neurology devices - EKG electrodes, electroconductive media, cardiopulmonary bypass devices/accessories, physiological monitor, blood pressure monitor transducer, central nervous system shunt, implantable clip

(6) Operating Room devices - lacrimal stents and intubation sets, electrosurgical cutting and coagulation instruments, bone fixation screws, spinal interlaminal fixation appliance, hysteroscope

This bar graph illustrates the number of reported medical devices by type in 2011 KidNet reports. The 157 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to device type; the y-axis corresponds to the number of reports. Left to right description of image: of the 157 devices reported in 2011, the tallest data point, depicted by a light purple bar, shows that 86 reports involve Intravenous (IV) devices. The burgundy data point shows that 33 reports involve Anesthesia/Respiratory (AN/Respiratory) devices. The yellow data point shows that 11 reports involve General Hospital devices. The light blue data point shows that 11 reports involve Gastroenterology/Urology (GI/GU) devices. The dark purple data point shows that 10 reports involve Cardiovascular (CV)/Neurology devices. The salmon data point shows that 6 reports involve Operating Room devices.

Reported patient demographics include patient age and gender. Patient gender was provided in 131 of the 153 KidNet reports. Reports involving males represent 58 percent of reported patient gender.

This pie chart illustrates the number of 2011 KidNet reports that specify patient gender. The 131 reports are categorized by gender, specifically by male and female. Of the 131 reports, 76 reports involving male patients were submitted, which are depicted by a light purple pie wedge. 55 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

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/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082188.pdf.

Patient ages provided in 142 of the 153 KidNet reports range from 1 day to 21 years with the largest number of reports involving patients 30 days to 2 years old. This is a change from 2010 where the majority of KidNet reports are associated with patients 0-30 days old.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2011 KidNet reports. The 142 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 142 reported patient ages in 20``, the light purple data point shows that 35 reports involve newborn patients (0-30 days). The tallest data point, depicted in burgundy, shows that 46 reports involve infant patients (30 days-2 years). The yellow data point shows that 32 reports involve child patients (2 years-12 years). The light blue data point shows that 29 reports involve adolescent patients (12-21 years).

Information on the device user in reported events was provided in 74 of the 153 KidNet reports with the nurse most frequently cited as the device user, consistent with reported events from 2010.

This bar graph illustrates the number of reports by device users - who was operating the device at the time of the event – in 2011 KidNet reports. 74 reports indicate the device user. The x-axis corresponds to specific device user; the y-axis corresponds to number of reports. Left to right description of image: of the 74 reports indicating device user in 2011, the tallest data point, depicted by a light purple bar shows that 56 reports specify nurses were operating the reported device at the time of the event. The burgundy data point shows that 8 reports show that Allied Health Providers were operating the reported device at the time of the event. The yellow data point shows that 6 reports identify a doctor as the user operating the reported device at the time of the event. The light blue data point shows that 2 reports state patients were operating the reported device at the time of the event. The dark purple data point shows that 2 reports indicate that the user was unknown.

As part of MedSun’s education and outreach efforts, KidNet sponsored a webcast on Phototherapy and Cooling Device Safety in Neonatal Patients featuring educators from a participating MedSun KidNet hospital. The webcast discussed how to optimize safety considerations when using devices used for phototherapy and cooling therapy with case study examples of problems reported to MedSun.
Presentation slides with audio and a printable transcript of the program can be accessed at:
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm280655.htm

Additional educational materials from prior MedSun KidNet programs are available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112724.htm.

Recognizing and reporting medical device problems seen in neonatal and pediatric clinical settings promotes patient safety. In 2011 alone, MedSun KidNet reports contributed to four recalls and several manufacturer actions taken to address device problems that were reported.
The recalls involve:

(1) a temperature probe used in used in conjunction with a measuring/monitoring device to continuously measure or monitor a patient's core body temperature, recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105007

(2) an ambulatory infusion pump intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patient-controlled analgesia), recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?i d=100377

(3) an inline filter for the patient airway system of a respirator or an anesthesia machine for the measurement of end-tidal CO2 in infants and neonates, recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99419

(4) a drug delivery system used with ventilators to deliver a preset concentration of nitric oxide for inhalation for critically ill patients, recall link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104896

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 MedSun hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

Together, we can continue to make recognition and reporting of actual and potential medical device-related problems a model for patient safety.

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