Device product
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Z-2722-2020
Product summary
- Event
- Event 85691
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7854
- Official record key
device-enforcement:Z-2722-2020
Official wording
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Code information: During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.
Distribution pattern: Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
Derived failure modes
-
Unknown
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.