Device product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Z-2734-2020
Product summary
- Event
- Event 85912
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 35616 units
- Official record key
device-enforcement:Z-2734-2020
Official wording
Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Code information: Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Distribution pattern: Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
Derived failure modes
-
Unknown
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.