Device product
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Z-2662-2018
Product summary
- Event
- Event 80490
- Status
- Terminated
- Classification
- Class II
- Quantity
- 276 units
- Official record key
device-enforcement:Z-2662-2018
Official wording
Reason: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
Code information: Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421
Distribution pattern: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
Derived failure modes
-
Unknown
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.