Spontaneous.Pt reports 4 of her cadd extension sets leaked around the filter area; date not provided.Lot number 4091449, expiration date 01/04/2026.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we replace [mfr] the device? yes; did the pt have a backup they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes.Reported to (b)(6) by pt/caregiver.
|