Device product
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Z-1147-2013
Product summary
- Event
- Event 64770
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195 units total (140 units Domestic, 55 units Foreign)
- Official record key
device-enforcement:Z-1147-2013
Official wording
Reason: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Code information: Lot numbers: 102810, 010311 and 111810.
Distribution pattern: Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
Derived failure modes
-
Unknown
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.