Spontaneous.Pt's husband reported that one of pt's remodulin premix cassettes were not working; unable to obtain the lot number.Husband stated that the patient did use one cassette from emergency bag.Patient was able to use emergency cassette and continue the infusion.No changes in symptoms or meds since last month reported.No other information provided.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? yes did the patient have a backup device they were able to switch to? yes was the patient able to successfully continue their infusion? yes is the infusion life-sustaining? yes.Reported to (b)(6) by: patient/caregiver.
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