Q2 CHECKMATE EXTENSION SET
Received Oct 24, 2015 · Event occurred Sep 28, 2015
Report 1649914-2015-00093 · MDR key 5173761
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
9541Lot number
0488075A03
Product problems
- Disconnection
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HOSPITAL AMBULATORY SURGERY SUPERVISOR (RN) REPORTED AN ISSUE ENCOUNTERED WITH THE Q2 CHECKMATE EXTENSION SET. SHE REPORTED THAT THE CRNA OBSERVED THAT WHEN PATIENTS ARE TAKEN BACK INTO THE OR, THERE ARE ISSUES WITH THE IV PORTS BECOMING DISCONNECTED. THE CRNA HAD TOLD HER THIS OCCURS ON THE ANESTHESIA TUBING LINE, AND NOT THE ONE THAT CONNECTS TO THE CONTINUOUS IV TUBING. THE REPORT STATED THEY TYPICALLY WILL DISCOVER THE ISSUE BECAUSE FLUIDS ARE LEAKING OR BLOOD IS SEEN IN THE TUBING. THE FLUIDS BEING ADMINISTERED AT THE TIME WOULD BE PROPOFOL, TRANEXAMIC ACID, OR SOME ANTIBIOTICS. THERE HAVE NOT BEEN ANY PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. THE HOSPITAL SHIPPED A SAMPLE TO THE MANUFACTURER FOR EVALUATION.
Additional Manufacturer Narrative
VISUAL EVALUATION OF THE DEVICE SAMPLE DID NOT FIND ANY ANOMALIES OR CAUSE FOR THE REPORTED COMPLAINT. THE USER HAD CONFIRMED THEY WERE NOT TIGHTENING THE CAP AFTER CONNECTING THE TUBING TO THE CHECKMATE. THE INSTRUCTIONS ARE INDICATED IN THE IFU. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.