GPS III MINI KIT W/30ML ACDA
Received Jun 20, 2012 · Event occurred May 17, 2012
Report 0001825034-2012-00857 · MDR key 2623255
Device
Generic name
Supplies, Blood Bank
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
800-0505A
Lot number
002126
Product problems
- Leak/Splash
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT AN ELBOW PROCEDURE ON (B)(6), 2012. DURING THE PROCEDURE, AS THE SURGEON WAS EXTRACTING PLATELET POOR PLASMA, PLATELET RICH PLASMA LEAKED INTO THE PLATELET POOR PLASMA CHAMBER. THE PROCEDURE WAS COMPLETED USING ANOTHER KIT, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR OCCURRED.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF RETURNED DEVICE FOUND THAT THE BUOY POSITION AND THE NUMBER OF RED BLOOD CELLS BELOW THE BUOY WERE ACCEPTABLE. DUE TO THE DRIED BLOOD AND PLASMA, IT WAS NOT POSSIBLE TO DISASSEMBLE AND EVALUATE THE COMPONENTS DIMENSIONALLY. EVALUATION RESULTS WERE INCONCLUSIVE.