GPS III SINGLE KIT W/30ML ACDA

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D4; D10; G4; G7; H1; H2; H3; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE BLOOD DID NOT FULLY FRACTIONATE. DEVICE NOT RETURNED. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

Description of Event or Problem

IT WAS REPORTED APPROXIMATELY THREE (3) MONTHS AGO, A STANDARD GPS KIT WAS USED IN A CLINICAL SETTING. AFTER THE SPIN, THE CANISTER WAS REMOVED FROM THE CENTRIFUGE AND THE BLOOD WAS NOT SEPARATED CORRECTLY. THE KIT WAS DISCARDED AND NOT USED ON THE PATIENT.