Spontaneous.Patient reported was mixing and the syringe popped off when inserting the second syringe with 50ml.Cassette lot number 3971696, expiration date 06/17/2025; syringe lot number 0339309, expiration date unknown.No harm to patient.No interruption in therapy.Unknown if product available for return.No further information provided.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? no; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; reported to (b)(6) by pt/caregiver.
|