Device product

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

Z-2465-2023

June 30, 2023

Class II

Product summary

Firm: Cardiac Assist, Inc
Event: Event 92748
Status: Ongoing
Classification: Class II
Quantity: 2 units
Official record key: device-enforcement:Z-2465-2023

Official wording

Reason: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Code information: S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972

Distribution pattern: US Nationwide distribution in the states of IL, FL.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,