CAREFUSION
Report
- Report Number
- 2021710-2014-00017
- Event Type
- Injury
- Date Received
- April 2, 2014
- Date of Event
- February 18, 2014
- Report Date
- February 18, 2014
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THE FOREIGN USER DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION CONTAINED ON EMAILS RECEIVED BY A CAREFUSION REPRESENTATIVE FROM A REPRESENTATIVE OF THE FOREIGN USER FACILITY. (B)(4). THE AVEA COMPREHENSIVE CLIO VENTILATOR IS NOT APPROVED FOR SALE WITHIN THE UNITED STATES. ON (B)(6) 2014 CAREFUSION DETERMINED THIS EVENT WAS A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT AND SUCH WAS A REPORTABLE EVENT. AS THE FOREIGN USER FACILITY WAS UNABLE TO PROVIDE CAREFUSION WITH THE SERIAL NUMBER OF THE DEVICE THAT WAS INVOLVED IN THE INCIDENT, CAREFUSION HAS DETERMINED THAT ALL FIVE OF THE AVEA COMPREHENSIVE CLIO VENTILATORS AT THE FOREIGN USER FACILITY SHOULD BE EVALUATED TO ENSURE THAT ALL OF THEM ARE OPERATING AS INTENDED. CAREFUSION IS CURRENTLY IN THE PROCESS OF MAKING ARRANGEMENTS TO HAVE A CAREFUSION REPRESENTATIVE OR A REPRESENTATIVE OF THE LOCAL FOREIGN DISTRIBUTOR TO GO TO THE FOREIGN USER FACILITY AND EVALUATE THESE DEVICES. ONCE CAREFUSION HAS BEEN ABLE TO MAKE ARRANGEMENTS TO HAVE ALL FIVE OF THE AVEA COMPREHENSIVE CLIO VENTILATORS AT THE FOREIGN USER FACILITY EVALUATED AND THE EVALUATIONS ARE COMPLETE. CAREFUSION WIL SUBMIT A FOLLOW-UP MEDWATCH REPORT.
THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS COPIUED FROM AN EMAIL RECEIVED BY A CAREFUSION REPRESENTATIVE FROM A FOREIGN USER FACILITY REPRESENTATIVE ON FEBRUARY 18, 2014. " LAST WEEK WE HAD A TERM BABY (3.6 KG) WITH SEVERE PPHN IN OUR UNIT. WE THINK THE PPHN WAS CAUSED BY MATERNAL NSAID USE BUT THERE MIGHT ALSO BE SOME MILD LUNG DISEASE PRESENT. BABY WAS SEVERELY HYPOXIC, HYPOTENSIVE (SBP LESS THAN 30 MMHG) AND FOR THAT REASON TREATED WITH INOTROPES AND HFOV. WE DECIDED TO MOVE THE BABY TO (B)(6) FOR ECMO. BEFORE DOING THIS WE TRANSFERRED THE BABY FROM HFV TO TCPL/AC-VG ON THE AVEA. WE SET A VT OF 23 ML AND THE AVEA NEEDED PEAK PRESSURES OF 34 CMH2O TO APPROACH THESE VOLUMES. FOLLOWING THIS TRANSFER THE PATIENT WAS SEVERELY HYPOXIC/HYPERCAPNIC/HYPOTENSIVE. SWITCHING VG OFF AND ON MADE NO DIFFERENCE. WE INCREASED INOTROPES AND SBP SLOWLY INCREASED. BLOOD GAS BEFORE TRANSPORT ON THE AVEA: PH6. 95/PCO2 82/-16.1/PAO2 25. WE THEN TRANSFERRED THE BABY TO THE TRANSPORT INCUBATOR AND CONNECTED THE BABY TO THE LEONIE WITH PEAK PRESSURE OF 34 CMH2O. TO OUR SURPRISE, VT DOUBLED TO 46 ML (MEASURED AT THE Y-PIECE). WE QUICKLY REDUCED THE PRESSURES TO 25CM H2O STILL HAVING A VT OF 36ML. FIRST BLOOD GAS AFTER SWITCH TO LEONIE: PH 7.48/PCO2 29/-1.2/PAO2 470! WE REPEATED THE BLOOD GAS, SIMILAR RESULTS. THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE EVENT AND THE CONDITION OF THE PATIENT WAS COPIED FROM AN EMAIL RECEIVED BY A CAREFUSION REPRESENTATIVE FROM A FOREIGN USER FACILITY REPRESENTATIVE ON (B)(6) 2014. "UNFORTUNATLEY, THE SERIAL NUMBER WAS NOT RECORDED. SO I AM UNABLE TO TRACE THE SPECIFIC DEVICE. WE USE F AND P MR850 HEATERS WITH F AND P RT235 DUAL HEATED CIRCUITS. SETTINGS WERE: TCPL/AC WITH VG OF 24 ML (3.6 KG), RATE OF 40/MIN, 100% O2, TI = 0.5 S, PIP LIMIT OF 40 CMH2O. PATIENT WAS BREATHING 80/MIN." "FOLLOW-UP: PATIENT RETURNED TO OUR CENTER WITHIN 2 DAYS NEVER REACHING ECMO CRITERIA AND IS NOW EXTUBATED AND DOING FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200045 | CAREFUSION | VENTILATOR, CONTINUOUS, FACILITY USE/ CBK | CBK | CAREFUSION | AVEA COMP CLIO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ASKU | Required Intervention | FISHER PAYKEL MR850 HUMIDIFIER| FISHER PAYKEL RT235 DUAL HEATED WIRE PAT CIRCUIT |