Device product
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Z-0996-2013
Product summary
- Event
- Event 63621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0996-2013
Official wording
Reason: An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Code information: Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Distribution pattern: Distributed in the state of NH.
Derived failure modes
-
Unknown
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.