MedSun: Newsletter #13, March 2007

By: Jill Marion, BSE, Patient Safety Staff

What Is KidNet?
KidNet is a specialty network of the Medical Product Safety Network (MedSun). It is focused on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units (NICUs and PICUs).

What Are the Goals and Objectives of KidNet?
KidNet Goal: To enhance pediatric patient safety associated with medical device use in the clinical setting by healthcare professionals’ recognizing, reporting, and understanding of medical-device related adverse events.

KidNet Objectives:
Increase the number and quality of signals for adverse events associated with devices used in pediatric patient populations
•To identify, understand and share postmarket device safety issues relevant to pediatric patient populations with KidNet participants, FDA, and the pediatric clinical community.
•To utilize the KidNet community as an interactive venue or real-time ‘laboratory’ to validate and understand device-related adverse event signals identified by FDA and KidNet participants.

Who Can Participate in KidNet?
MedSun facilities interested in reporting adverse events involving devices used in NICUs or PICUs including reports of:

•Patient, family member, or healthcare provider death or serious injury, or those that represent ‘potential for harm, ‘near miss’, or ‘close call’ events
•Problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended
•Problems with devices without pediatric indications for use that fail or don’t perform optimally because of anatomic or physiologic differences between adults and children (i.e. sizing, fit affects delivery of therapy).

Pediatric MedSun Success Stories (2006-2007):
Neonatal PICC Catheter: A minor injury was experienced by a critically ill NICU patient when the dual lumen PICC catheter was noted to be leaking and required immediate removal and replacement. CDRH/FDA followup with the firm identified that the firm had begun an investigation to address the increasing trend of PICC complaints. The investigation concluded that the source of the leak was use error and the sales force is reenforcing the instructions for use with their customers.

Infusion Pump: A report described an adverse event with 15cc of air noted in the lipid syringe and halfway down the tubing of an infant‘s IV lipids. The lipids had infused too fast and the facility’s clinical engineering department found that the syringe had a dent/defect in it. CDRH/FDA follow-up with the firm indicated that the firm identified a manufacturing defect, which is being addressed.

Syringe Pump: A pediatric patient was found holding a syringe of medication, while standing in the patient’s crib. The syringe of medication had been properly placed in the syringe pump, even though the patient was able to pull on the tubing, reaching the syringe and removing it from the pump. CDRH/FDA follow up with the manufacturer indicated that although the event was the only reported issue of this type; a lock box was created to prevent this issue from reoccurring.

Infant Warmer: An infant warmer had an upgrade kit issued following a manufacturer investigation in September 2006. After that upgrade, a MedSun user facility reported an event of the bed platform falling approximately 1 foot and tilting sharply, as a patient was being repositioned on the bed. CDRH/FDA followup with the firm indicates the firm identified the cause for the reported problem, resulting in a recall.

Prospective KidNet Timeline:
•KidNet Web-based orientation May 17, 2007 3:00 p.m. EDT
•KidNet data collection begins June 1, 2007
•New hospital group orientation June 25, 2007 Annapolis, MD
(KidNet reporters welcome) July 13, 2007 San Diego, CA
•Educational Audioconference: August/September 2007 3:00 p.m. EDT
“Improving Patient Safety By (specific date to be Reporting Problems With announced with Medical Devices” replays available)
•KidNet participant roundtable October 18, 2007 3:00 p.m. EDT to discuss and obtain feedback on reported events and safety issues of concern – via Webcast or audioconference

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