GPS III MINI KIT W/30ML ACDA
Received Sep 15, 2020 · Event occurred Aug 27, 2020
Report 0001825034-2020-03488 · MDR key 10535189
Device
Generic name
Biologics
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
800-0505A
Lot number
802656
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). (UDI): N/A. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED FOLLOWING PATIENT CAME IN TO AN OUT PATIENT URGENT CARE FOR TREATMENT. THE EVENT HAPPENED DURING THIS APPOINTMENT. THE GPS III MINI TECHNIQUE, OBTAIN THE BLOOD WITH ACDA SPINNING DOWN WITH THE APPROPRIATELY FILLED COUNTER BOI IN PLACE, THERE WAS A SMALL CLOT AND THE SEPARATION FAILED. THE DOCTOR WAS LEFT WITH 16ML DRAW. NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.