Device product

PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

Z-2438-2025

July 28, 2025

Class II

Product summary

Firm: VANTIVE US HEALTHCARE LLC
Event: Event 97233
Status: Ongoing
Classification: Class II
Quantity: 2449 units
Official record key: device-enforcement:Z-2438-2025

Official wording

Reason: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

Code information: UDI 07332414126018, All serial numbers

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure