Patient: deceased.Product impact: no indication product failure caused patient death.However, because clotted blood cannot be returned this does have a negative impact on patient care.Previous occurence: product already reported to fda as possibly defective; this is a second report.Previous report on (b)(6) 2022.Note this occurrence happened on a different patient.Clinical notes: on (b)(6) 2022 at 2111, patient clotted off crrt filter (lot 21l0010ce), requiring the circuit to be changed.On (b)(6) 2022 at 0332 the patient again clotted off his filter (same lot #, 21l0010ce).Patient again clotted on (b)(6) 2022 at 0900 requiring the circuit to be changed (using new lot # for this change).Additional notes from clinicians: catheter was flushed frequently.No anticoagulant utilized.Other contributors to event: materials management quarantined the lot as we suspected it was a bad lot based on our previous event on (b)(6) 2022.However, we received more product from the distributor which was the same lot number as before, which we failed to quarantine, thus resulting in our hospital using this lot again.This is a total of 6 occurrences of alarming and clotting with this particular lot and no failures with other products with different lot numbers.Fda safety report id # (b)(4).
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