Meridian Hemodialysis Instrument 의 리콜

Recall

36361

Class 2

Z-0169-2007

2006-09-06

2006-11-14

Terminated

United States

2006-12-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48483

The meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.

Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute for clinical monitoring of the patient for adverse events.' Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 2. General questions were directed to The Center for One Baxter at 1-800-422-9837.