Featured HomeNet Report of Interest
MedSun: Newsletter #54, November 2010

In this featured HomeNet report of interest, an infusion pump was connected to a home care patient with the intent to deliver penicillin at a rate of 19.6 ml/hour. The drug was delivered at a rate of 40.5 ml/hour instead. The home care nurse assumed that the rate had been set by the out-patient pharmacy; however, the pharmacy technician who sent the pump to the patient's home doesn't normally assume this responsibility.

While the incident was the result of process mistakes rather than a device-related problem, this report is important because it validates the added complexities that arise as it relates to device set-up upon patient discharge to the home setting.

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 or
•Issues with device appropriateness and compatibility in the home setting.

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. September 29, 2010.

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