Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Update-Haemonetics Corp

DATE NOTIFICATIONS INITIATED:

 

October 18-26, 2004

 

PRODUCT:

 

Automated Blood Cell Separator, Haemonetics Mobile Collection Systems
MCS+ 9000
MCS+ 7000
MCS+ 8100

 

Model Numbers
LN 09000-110-E
LN 07000-110-E
LN 08100-110-E

 

MANUFACTURER:

 

Haemonetics Corporation
Braintree, Massachusetts

 

REASON:

 

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.