GPS III PLATELET CONCENTRATION SYSTEM
Received Jul 24, 2025 · Event occurred Jun 26, 2025
Report 0001825034-2025-02218 · MDR key 22586609
Device
Generic name
Supplies, Blood-bank
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
800-1003A
Lot number
0212065
Product problems
- Inadequate Filtration Process
- Inadequate Filtration Process
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE CLINIC ATTEMPTED TO DO A PRP BUT ENCOUNTERED A DOUBLE BUFFY LAYER. THEY OPTED NOT TO INJECT THE PRP BACK INTO THE JOINT BECAUSE THEY WERE UNSURE IF THE DOUBLE BUFFY LAYER WOULD HAVE ANY CLINICAL IMPACT ON THE EFFICACY OF THE PRP PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H5. THE CORRECTION DOES NOT CHANGE THE PREVIOUS INVESTIGATION. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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.
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/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS IDENTIFIED THAT THERE IS A DOUBLE BUFFY LAYER. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO DEVICE PROBLEM IDENTIFIED. REVIEW WITH DEVELOPMENT TEAM CONFIRMED THAT THE PRESENCE OF A DOUBLE BUFFY LAYER IS NOT A DEVICE PROBLEM AND THE PRP STILL MEETS ACCEPTANCE CRITERIA. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.