Featured HomeNet Report of Interest
MedSun: Newsletter #51, August 2010

Your reports of adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device-related safety concerns are of special interest to FDA and MedSun. HomeNet is particularly interested in learning about problems with medical devices used in the home as a function of the unique use environment, such as:

•Concerns with device instruction for use and labeling
•Issues with patient and caregiver training
•Issues with device appropriateness and compatibility in the home setting

In this featured HomeNet report of interest, the patient was unable to initiate total parenteral nutrition (TPN) infusion on two Cadd infusion pumps manufactured by Smith’s Medical. Shop tests of the pump revealed no defects and the TPN fluid intended for delivery was found to be within the manufacturer's specifications. Home care pharmacy was not aware of any extenuating circumstances that may have existed that would explain why two pumps might have been reported to fail on the same patient. Given these circumstances, the most likely explanation was that the patient had forgotten instructions on how to operate the pump after initially successfully utilizing the pump.

This event is particularly interesting because it provides information about the patient’s ability to understand and comply with instructions for device operation. This report also includes useful information learned by the facility when they tested the device in question and in their communications with other segments of their facility, specifically home care pharmacy.

If you become aware of problems with devices indicated for use in the home or with devices that are typically used in the home setting, with devices that fail or do not perform as intended, or those that represent a potential for harm, please report these events through your MedSun representative, if you are a member of MedSun or HomeNet., 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.

Please see the MedSun report provided under Additional Information below.

Additional Information:

MedSun Report. March 16, 2010.

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