Device Recall Baxter Meridian Hemodialysis Instrument 의 리콜

Recall

28475

Class 2

Z-0758-04

2004-03-10

2004-07-20

Terminated

United States

2006-10-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31970

Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the meridian.

Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2. Baxter developed a permanent fix -- an enhanced air detector with improved sensitivity, making it capable of detecting air bubbles of a smaller size. Letters were sent to all Meridian customers on 7/11/05, informing them of the availability of the new detector and that a Baxter Field Service Engineer would contact them to schedule the upgrade.