Patient reported remodulin tubing leaks at filter site; okay to prime but leaks after 1 to 2 days.This has happened a couple of times.Once during the night, noticed clothes wet, and had symptoms of lightheadedness from remodulin not running at full dose.Patient does not have lot number of defective tubing on hand, but will call pharmacy back later with this.Patient has tubing available for return.No further information available.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? yes.Did we [mfr] replace device? no, patient had more on hand.Did the patient have a backup device they were able to switch to? yes, able to continue infusion.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Reported to (b)(6) by: patient/caregiver.
|