KidNet - Get Set for Pediatric Patient Safety
MedSun: Newsletter #35, April 2009

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

KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It is focused 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, 37 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.

The data discussed in this article represent reports received in 2008.

For calendar year 2008, we received 125 reports on device–related adverse events from MedSun KidNet hospitals.

This bar graph illustrates the number of KidNet reports received by quarter. These reports were submitted by KidNet participant sites over the 2008 calendar year. The 125 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 125 KidNet reports received in 2008, the light purple data point shows that 21 KidNet reports were received in the 1st quarter. The burgundy data point shows that 32 KidNet reports were received in the 2nd quarter. The yellow data point shows that 25 KidNet reports were received in the 3rd quarter. The tallest data point, depicted by a light blue bar shows that 47 KidNet reports were received in the 4th 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 (96%) of reports from KidNet in 2008 involve device-related problems described as minor harm, potential for patient harm, or close call events.

Two percent (2%) of the reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury), and 2% of the reports were about a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2008. The 125 reports are categorized by event type, specifically by the categories of: product problems, serious injury, and death. Of the 125 reports, 119 reports were submitted as product problems, depicted by a light purple pie wedge. 3 reports were submitted as serious injury and 3 reports were submitted as death, which are depicted by burgundy and yellow pie wedges, respectively.

There are 3 reports (2% of 2008 KidNet reports) indicating intervention was required to prevent impairment or damage (serious injury events): (1) an event involving a peripherally inserted central venous catheter (PICC) that was noted to be sheared, which then migrated; the patient was taken to the cardiac cath lab for percutaneous removal, (2) an event involving an IV tubing set with the single lumen central line broken above the connector on the Huber needle resulting in explant of the line and replacement with a new one and, (3) an event associated with a life-threatening outcome involving a programmable ventriculoperitoneal shunt with massive over drainage several weeks after placement. The programmable setting of the shunt valve was checked, found to be open at the lowest setting, and was immediately changed to ‘closed.’ A CT scan a few days later showed improvement in the size of ventricles and slight decrease in the size of subdural hematoma.

The 3 reports (2% of 2008 KidNet reports) associated with patient deaths include an event of a high frequency oscillating ventilator that was being used on the patient that stopped oscillating and lost all pressures, requiring bagging of the patient – the patient later died. The second event involves an infusion pump that was accidentally programmed for 68 ml/hour instead of the ordered rate of 6.8 ml/hr. resulting in overinfusion of total parenteral nutrition (TPN). The third event is associated with a cardiac monitor placed on a baby and when the parents came in they found the monitor turned off. When the monitor was checked by turning it back on, the monitor went blank again, without an alarm sounding, and it was later found the cord had worked itself loose. No further information is provided about the device problem contributing to the patient death.

The 125 KidNet reports reference 151 devices, of which there are 46 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 46 reported device types have been grouped by clinical medical specialty as defined in the listing below for the chart that follows.

(1) IV products – (PICCS, ports, needles, syringes, tubing, pumps)

(2) CV products – (cardiovascular monitors, EKG electrodes, cardiopulmonary bypass devices, implantable cardiac defibrillators, external defibrillators, external pacemakers, vascular hemostasis devices)

(3) GI/GU products – (enteral feeding pumps & GI tubes, dialysis delivery systems, and urinary and hemodialysis catheters)

(4) Respiratory products – (tracheobronchial suction catheters, ventilators, cannulas, humidifiers, respirators, regulators)

(5) All others - (general hospital, general surgery, neurology, IVD devices)

This bar graph illustrates the number of reported medical devices by type in 2008 KidNet reports. The 151 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 151 devices reported in 2008, the tallest data point, depicted by a light purple bar, shows that 76 reports involve Intravenous (IV) devices. The burgundy data point shows that 22 reports involve Cardiovascular (CV) devices. The yellow data point shows that 22 reports involve Gastroenterology/Urology Devices (GI/GU) devices. The light blue data point shows that 17 reports involve Anesthesia/Respiratory (AN/Respiratory) devices. The dark purple data point shows that 14 reports involve All Other device types.

Reported patient demographics include patient ages and gender, of which information was provided for 116 of the 125 reports.

This pie chart illustrates the number of 2008 KidNet reports that specify patient gender. The 116 reports are categorized by gender, specifically by male and female. Of the 116 reports, 69 reports involving male patients were submitted, which are depicted by a light purple pie wedge. 47 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

Patient ages that were provided in the 125 reports range from 1 day to 21 years. 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. Note that there are more patient ages than reports as reports may contain events with more than one patient.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2008 KidNet reports. The 130 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 130 reported patient ages in 2008, the light purple data point shows that 47 reports involve newborn patients (0-30 days). The tallest data point, depicted in burgundy, shows that 51 reports involve infant patients (30 days-2 years). The yellow data point shows that 16 reports involve child patients (2 years-12 years). The light blue data point shows that 16 reports involve adolescent patients (12-21 years).

Although the focus of KidNet is on medical device-related adverse events occurring in the NICU or PICU, reports on events occurring in other areas of the hospital are welcomed. Information on the area where the reported event occurred was provided in 83 of the 125 reports; most reports list ‘critical care.’ A large number of reports indicate ‘other’ as the event location. Recent programming changes provide MedSun KidNet reporters with an option of specifying NICU or PICU as the area where the event occurred.

This bar graph illustrates the number of reports by patient care area, or event location, submitted by KidNet participant sites in 2008. The 83 reports, which specify adverse event location, have been grouped by 5 different patient care areas, specifically: critical care, other, patient room, operating room, and skilled nursing unit. The x-axis corresponds to patient care area; the y-axis corresponds to the number of reports. Left to right description of image: of the 83 KidNet 2008 reports with patient care areas specified, the tallest data point depicted by a light purple bar shows that 36 reports list critical care as the patient care area. The burgundy data point shows that 25 reports specify patient care areas other than those depicted in the graph. The yellow data point shows that 15 reports indicate the patient care area as the patient room. The light blue data point shows that 6 reports cite the operating room as the patient care area. The dark purple data point shows that 1 report identifies a skilled nursing unit as the patient care area.

Information on who was operating the device at the time of the event is available in 73 of the 125 reports; most reports (52) indicate ‘nurse’ as the device user.

This bar graph illustrates the number of reports by device users - who was operating the device at the time of the event – in 2008 KidNet reports. Of the 125 KidNet 2008 reports, 73 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 73 reports indicating device user in 2008, the tallest data point, depicted by a light purple bar shows that 52 reports specify nurses were operating the reported device at the time of the event. The burgundy data point shows that 9 reports show that doctors were operating the reported device at the time of the event. The yellow data point shows that 8 reports identify allied health providers as the user operating the reported device at the time of the event. The light blue data point shows that 4 reports state patients were operating the reported device at the time of the event.

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 two Roundtable webcasts in 2008. The May Roundtable, Recently Reported Safety Issues Involving Pediatric and Neonatal Patients discussed safety issues identified in recently reported adverse events from MedSun NICUs and PICUs including: problems encountered during the administration of supplemental oxygen using head hoods, incubator and infant warmer fires, and bedside monitor failures.

The November Roundtable, Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events featured Luer connector experts from FDA and Beaumont Hospitals discussing major factors that contribute to Luer-connector misconnections and examples of adverse events associated with these misconnections. Presentation slides and audioconference transcripts are available for these, along with other MedSun and KidNet programs, at http://www.fda.gov/cdrh/medsun/conference.html.

The following are 2 examples of device-related problems reported through KidNet in 2008 that represent just a few of the many successes in problem identification, information sharing, and solution strategies developed by device users, FDA, and manufacturers to address and improve the safety of medical device use in the clinical setting.

Cardiovascular Monitor: Three reports from the same KidNet hospital cite problems with a single manufacturer’s model cardiovascular monitor screen spontaneously going blank while in use on patients in the neonatal intensive care unit (NICU). No patient injuries were reported to be associated with this problem; however, the hospital reported the problem due to the potential for harm to the patient. FDA’s follow-up with the KidNet hospital’s nursing and biomedical departments, along with FDA follow-up with the manufacturer resulted in the firm’s identification of a root cause. As a result of this report and information sharing between the hospital, FDA, and the manufacturer, the firm issued a Dear Customer Letter to current customers with the subject device model to alert them of the monitor blanking problem and the availability of replacement parts.

Central Venous Catheter: A MedSun KidNet report describes problems encountered during an attempted catheter flush prior to placement in the patient because the catheter lumen was obstructed. Information sharing between FDA and the reporter, as well as FDA follow-up with the manufacturer, resulted in the firm identifying the catheter lumen was obstructed due to debris during the manufacturing process. The manufacturer has made changes to address the problem.

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 medical device-related adverse events a model for patient safety.

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