Pt's husband spontaneously called to report that some of the tubing twists up and disconnects.He stated that it is not secured / tight and it takes 2-3 times to connect correctly.He does not have lot number because the box was discarded.Advised that pharmacy will ship more tubing and to call the pharmacy with lot number if it happens again.Pt had different tubing set to switch to and continue his life sustaining infusion.Pharmacy shipped more tubing.Did the pt have a backup device they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.Did the reported product fault occur while in use with a pt? no.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual device available for investigation? unk.Did we (mfr) replace device? yes.Reported to (b)(6) by pt/caregiver.
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