CENTRIFUGE 115V 50/60HZ DRUCKR
Received Feb 21, 2019 · Event occurred Feb 14, 2019
Report 0001825034-2019-00763 · MDR key 8357302
Device
Generic name
Blood Work Supplies
Manufacturer
Zimmer Biomet, Inc.Catalog number
755VES
Lot number
60120511
Product problems
- Device Difficult to Setup or Prepare
- Device Difficult to Setup or Prepare
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS BEEN RETURNED AND 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 THE CENTRIFUGE MALFUNCTIONED CAUSING THE BALANCING TO BE OFF, NOT ALLOWING FOR AN ACCURATE SPIN. THIS WAS IDENTIFIED IN AN OFFICE SETTING; NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.
Description of Event or Problem
NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.
Additional Manufacturer Narrative
REPORTED EVENT WAS CONFIRMED VIA VISUAL EXAMINATION OF THE RETURNED DEVICE. THE DEVICE EXHIBITS DAMAGE CONSISTENT WITH USE OVER TIME. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE IS ATTRIBUTED TO WEAR OUT DUE TO NORMAL USE. 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.