GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A

Additional Manufacturer Narrative

(B)(4). FOREIGN - EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K070026. THE COMPLAINT DEVICE IS REPORTEDLY IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE WHERE BLOOD WAS BEING SEPARATED UTILIZING THE GPS SYSTEM, THE PLATELET POOR PLASMA (PPP) AND PLATELET RICH PLASMA (PRP) DID NOT SEPARATE AS INTENDED. ANOTHER KIT WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF ACTUAL PRODUCT RECEIVED AND PHOTOS RECEIVED BY CUSTOMER. THE BLOOD IS A DARKER RED COLOR CONFIRMING THAT IT DID NOT PROPERLY SEPARATE AS INTENDED; THEREFORE, THE COMPLAINT IS CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY INFORMATION OR CONCLUSIONS, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.