COULTER ACT 5 DIFF CONTROL PLUS
Received Sep 23, 2011 · Event occurred Aug 6, 2009
Report 1061932-2011-01532 · MDR key 2276805
Device
Product problems
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PRODUCT WAS REPLACED AT THE TIME OF EVENT. SERVICE WAS NOT DISPATCHED. BASED UPON AVAILABLE INFORMATION ROOT CAUSE IS UNK.
Description of Event or Problem
THE CUSTOMER REPORTED THE VIAL OF ACT 5DIFF CONTROL HAD A LOOSE CAP AND LEAKED DURING SHIPMENT. THE LEAK WAS CONTAINED WITHIN THE PACKAGING BOX. THE CONTROL PRODUCT CONSISTS OF CONSISTS OF HUMAN ERYTHROCYTES, SIMULATED LEUKOCYTES, AND MAMMALIAN PLATELETS IN A PLASMA-LIKE FLUID. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT AND THERE WAS NO SPILL ON THE FLOOR OR COUNTER AND NO CONTROL MATERIAL SPILLED ON THE OPERATOR. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.