BIOMET BIOLOGICS COUNTERBALANCE
Received Jun 14, 2017
Report 0001825034-2017-03847 · MDR key 6639465
Device
Product problems
- Break
- Break
Patient
Not reported
- No Code Available
- No Code Available
Narrative
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. PRODUCT DEVICE CODE = JQO.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE UTILIZING A GPS KIT, THE COUNTER BALANCE WATER TUBE BROKE DURING CENTRIFUGATION. A NEW COUNTERBALANCE WAS PLACED IN THE CENTRIFUGE AND THE BLOOD WAS SPUN TO COMPLETE THE PROCEDURE, AFTER DELAYING PROCEDURE FOR FORTY-FIVE (45) MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO PATIENT INJURY NOR HARM. THE INITIAL REPORT WAS FILED IN ERROR AND SHOULD BE VOIDED. 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.