GPS MINI KIT W /ACD-A & BD -A/BLOOD D
Received Sep 17, 2019 · Event occurred Sep 5, 2019
Report 0001825034-2019-04171 · MDR key 9078987
Device
Generic name
Biologics, Instrument
Manufacturer
Zimmer Biomet, Inc.Catalog number
800-0670A
Lot number
190253
Product problems
- Separation Problem
- Separation Problem
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED TUBE NOTED SOME OF THE LIQUID, INSIDE OF THE TUBES HAS HARDENED WITH SOME STILL REMAINING IN A LIQUID STATE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE: THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLOOD DID NOT SEPARATE IN THE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.