FLOTRAC
Report
- Report Number
- 2015691-2023-18607
- Event Type
- Malfunction
- Date Received
- December 20, 2023
- Report Date
- July 18, 2024
- Manufacturer
- EDWARDS LIFESCIENCES, DR
- Product Code
- DQE
- UDI-DI
- 00690103194586
- PMA / PMN Number
- K043065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UDI RELATED DATA QUALITY UPDATES ONLY THE FOLLOWING ARE ADDITIONAL PRODUCT CODES FOR THIS DEVICE DRS TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR DXG COMPUTER, DIAGNOSTIC, PRE PROGRAMMED, SINGLE FUNCTION THE LOT NUMBER FOR THIS DEVICE WAS NOT PROVIDED AND IS UNKNOWN, THEREFORE, THE FULL UDI NUMBER IS NOT AVAILABLE. THE PRIMARY DI NUMBER IS (B)(4). THE FOLLOWING IS CORRECTED DATA, AS THE ORIGINAL IDENTIFICATION INFORMATION SENT DID NOT MATCH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID) D1 BRAND NAME: FLOTRAC. D2A COMMON DEVICE NAME CATHETER, OXIMETER, FIBEROPTIC. D2B DEVICE PRODUCT CODE DQE.
THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT EVALUATION FOUND THAT THE REPORTED ISSUE WAS NOT CONFIRMED. THERE WAS NO VISIBLE DAMAGE OR ABNORMALITY OBSERVED FROM THE ENTIRE UNIT. THERE WERE NO ERROR MESSAGES OBSERVED ON THE HEMOSPHERE MONITOR AND PRESSURE MONITOR WHEN THE SUSPECT FLOTRAC UNIT WAS CONNECTED. THE FLOTRAC DEVICE ZEROED AND SENSED PRESSURE ACCURATELY ON THE HEMOSPHERE UNIT AND THE PRESSURE MONITOR, RESPECTIVELY. PRESSURE DID NOT SHOW ANY DRIFT DURING THE OUTPUT DRIFT TESTING. INITIAL PRESSURE 150 MMHG, FINAL PRESSURE 150 MMHG FOR THE FLOTRAC SENSOR. THE DEVICE MET SPECIFICATIONS PER DRAWINGS. THE ELECTRICAL TESTING SHOWED THAT BOTH INPUT IMPEDANCE AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. THERE WAS NO DEFECT FOUND. NO ESCALATION IS REQUIRED. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO PRODUCT EVALUATION FINDINGS. SECTIONS G6, H2, H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT.
THE DEVICE HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT YET ARRIVED FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER IS UNKNOWN. ONCE THE PRODUCT EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL SUBMISSION WILL BE SENT WITH THE FINDINGS.
IT WAS REPORTED THAT THERE WERE INACCURATE ARTERIAL BLOOD PRESSURE VALUES WITH THE PRESSURE MONITORING FLOTRAC SENSOR. THIS OCCURRED DURING PATIENT MONITORING. THE BLOOD PRESSURE VALUES ON THE PATIENT BEDSIDE MONITOR WERE 5 TO 10MMHG HIGHER THAN WHAT WAS BEING DISPLAYED ON THE HEMOSPHERE MONITOR. THERE WERE NO ERROR MESSAGES THAT DISPLAYED. THERE WAS NO ABNORMAL WAVEFORM THAT DISPLAYED. THERE WAS NO TROUBLESHOOTING OR REPLACEMENT OF THE DEVICE THAT WAS PERFORMED. THE PRESSURE MONITORING DEVICE WAS ABLE TO BE ZEROED BEFORE USE. THERE WAS NO OCCLUSION, LEAKAGE OR KINK THAT OCCURRED. THE INFORMATION REGARDING THE EXPECTED VALUES AND WHETHER THE VALUES AND THE WAVEFORM MATCHED ARE NOT KNOWN. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT ARE UNAVAILABLE. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED TO THE PATIENT. THE OTHER EDWARDS COMPONENTS USED IN THE MONITORING WERE RULED OUT AS SUSPECT. THERE IS NO PATIENT HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2049776 | FLOTRAC | CATHETER, OXIMETER, FIBEROPTIC | DQE | EDWARDS LIFESCIENCES, DR | MHD6S | 00690103194586 | |
| 2301705 | FLOTRAC | CATHETER, OXIMETER, FIBEROPTIC | DQE | EDWARDS LIFESCIENCES, DR | MHD6S | 00690103194586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |