GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEM

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART#, GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEM, LOT 700931, QUANTITY 2. PATIENT WAS STUCK WITH NEEDLE ADDITIONAL TIMES. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE PATIENT¿S BLOOD WAS DRAWN INTO THE TUBE AND PLACED INTO CENTRIFUGE, THE COMPARTMENTS ON THE TUBE LEAKED AND DID NOT SEPARATE THE SPECIMEN PROPERLY. PATIENT¿S BLOOD SPECIMEN WAS NOT VIABLE. PATIENT¿S BLOOD WAS TAKEN AGAIN AND PLACED IN ANOTHER TUBE. ONCE THE BLOOD ENTERED THE TUBE THE COMPARTMENTS BEGAN TO LEAK AGAIN. THE BLOOD WAS THEN DRAWN FROM THE TUBE AND PLACED INTO ANOTHER TUBE FROM ANOTHER LOT NUMBER, WHERE PROCESSING WAS COMPLETE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

COMPLAINT SAMPLE WAS NOT RETURNED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AND THE PRODUCT WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. HOWEVER, IT IS NOTED THAT IT IS ACCEPTABLE FOR ANTICOAGULATED BLOOD TO FLOW AROUND THE BUOY. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.