Retiro De Equipo (Recall) de Baxter Meridian Hemodialysis Instrument

Recall

33632

Class 1

Z-0275-06

2005-12-14

Terminated

United States

2006-11-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42188

Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.

Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams showing the correct and incorrect use of the clips, provided labels, with placement instructions, to be placed on the Meridian machine indicating the correct and incorrect placement of tubing, and informed the users that replacement clips with single channels will be installed when they become available. Follow-up letters were sent to the accounts on 12/22/05, providing training material to ensure that the accounts are aware of proper blood tubing set-up and understand the conditions which may result in hemolysis, and on 12/23/05, informing them that the replacement clips were available for installation, giving the accounts the option of having Baxter install them or sending the clips to the account for self-installation.