Vaccines, Blood & Biologics
Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System-Haemontics Corp
DATE NOTIFICATIONS INITIATED:
October 18-26, 2004
Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System
Model Number: LN09000-110-E
Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit. A bowl base leak causes blood to leak out of the base of the bowl and into the waste bag. Haemonetics began equipping the MCS with a base leak detector starting with serial number 01M185. A Haemonetics service representative will contact consignees.
In the meantime, Haemonetics recommends that operators periodically observe the waste bag during a collection procedure. If there are indications of blood products in the waste bag, the procedure should be terminated.