WESTMED LLC
Report
- Report Number
- 2028807-2022-00021
- Event Type
- Injury
- Date Received
- November 8, 2022
- Date of Event
- October 19, 2022
- Report Date
- November 8, 2022
- Manufacturer
- WESTMED LLC
- Product Code
- CAI
- PMA / PMN Number
- K904538
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE ANAPOD HUMI-THERM HEATED AND HUMIDIFIED WICK BREATHING CIRCUIT DEVICE TO THE HELICOPTER OXYGEN AND THE ANAPOD TO THE HELICOPTER ELECTRIC OUTLET NOTED A FIRE IN THE CIRCUIT. THE CIRCUIT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE HELICOPTER. THE PATIENT HAD SOOT IN THE NARES AND DEVELOPED IMMEDIATE RESPIRATORY DISTRESS. AS IT CAUGHT FIRE AND BURNED THE NARES OF THE PATIENT AND CAUSED IMMEDIATE RESPIRATORY DISTRESS TO THE PATIENT, CAUSING THE PATIENT TO BE INTUBATED.
THE ANAPOD HUMI-THERM HEATED AND HUMIDIFIED WICK BREATHING CIRCUIT DEVICE TO THE HELICOPTER OXYGEN AND THE ANAPOD TO THE HELICOPTER ELECTRIC OUTLET NOTED A FIRE IN THE CIRCUIT. THE CIRCUIT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE HELICOPTER. THE PATIENT HAD SOOT IN THE NARES AND DEVELOPED IMMEDIATE RESPIRATORY DISTRESS. AS IT CAUGHT FIRE AND BURNED THE NARES OF THE PATIENT AND CAUSED IMMEDIATE RESPIRATORY DISTRESS TO THE PATIENT, CAUSING THE PATIENT TO BE INTUBATED. THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. THE REPORTED COMPLAINT ISSUE DESCRIPTION STATED, THE "DEVICE STARTED ON FIRE." ONE COMPLAINT WAS RECEIVED FOR PART NUMBERS A2003-1 AND A9244. THE COMPLAINT STATED THAT SHORTLY AFTER CONNECTING THE ANAPOD HUMI-THERMHEATED AND HUMIDIFIED WICK BREATHING CIRCUIT DEVICE TO THE HELICOPTER OXYGEN AND THE ANAPOD TO THE HELICOPTER ELECTRIC OUTLET A FIRE WAS NOTED IN THE CIRCUIT. THE CIRCUIT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE HELICOPTER. THE PATIENT HAD SOOT IN THE NARES AND DEVELOPED IMMEDIATE RESPIRATORY DISTRESS. THE PATIENT WAS INTUBATED AND WAS FOUND TO HAVE BURNS IN THE NARES WAS CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE FAILURE INCLUDES LOOSE SCREW WITHIN THE ANAPOD DEVICE, LOOPED HEATING WIRE, WICK MISSING PRIOR TO THE DEFORMITY, AND NOT ENOUGH WATER USED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH REQUIRED REPORTING TO THE CARB REVIEW BOARD FOR REVIEW. HOWEVER, GIVEN THE OBSOLESCENCE OF THIS DESIGN, THERE ARE NO CORRECTIVE ACTIONS OR MODIFICATION APPLICABLE TO THE REMAINING PRODUCTS; THEREFORE, A CAPA WAS NOT REQUIRED. THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM OCTOBER 1, 2020, TO MAY 29, 2024, FOR PART NUMBER A2003-1 (CONTROLLER, ANAPOD, DOMESTIC) UNDER FAILURE MODE "FUNCTIONAL ISSUE(S)", THIS IS THE FIRST COMPLAINT REPORTED FOR THIS FAILURE MODE. HOWEVER, THERE WERE SIXTEEN COMPLAINTS REPORTED FOR THE SAME PART NUMBER A2003-1 (CONTROLLER, ANAPOD, DOMESTIC) DURING THE SAME TIMEFRAME FOR OTHER FAILURE MODES. THE COMPLAINT HISTORY WAS REVIEWED IN (B)(4) FROM OCTOBER 1, 2020, TO MAY 29, 2024, FOR PART NUMBER A9244 (ANAPOD HUMI-THERM WICK TRANSPORT CIRCUIT) UNDER FAILURE MODE "FIRE", THIS IS THE FIRST COMPLAINT REPORTED FOR THIS FAILURE MODE. THERE WAS ONE COMPLAINT REPORTED FOR THE SAME PART NUMBER A9244 (ANAPOD HUMI-THERM WICK TRANSPORT CIRCUIT) UNDER (B)(4), DURING THE SAME TIMEFRAME FOR FAILURE MODE "NON-FUNCTIONAL COMPONENT(S)." BASED ON THE ATTACHED HHE CURRENT CONTROL MEASURES ARE ADEQUATE TO CONTROL THE RISK; THIS IS A COVERED RISK WITHIN THE RISK ANALYSIS FILE AND THERE ARE CURRENTLY NO OTHER COMPLAINTS FOR THIS ISSUE. PART NUMBER A9244 WAS THE PART NUMBER THAT WAS INVOLVED IN (B)(4). THIS CIRCUIT SKU WAS PART OF THE ANAPOD HEATED AND HUMIDIFIED CIRCUIT FAMILY THAT HAS SINCE BEEN DISCONTINUED BY AIRLIFE. THIS PRODUCT FAMILY WAS UNIQUE DUE TO THE COTTON WICK THAT WAS SUPPLIED TO THE CIRCUIT THAT ABSORBED THE WATER TO BE HUMIDIFIED TO THE PATIENT. ALTHOUGH THERE ARE MANY OTHER HEATED CIRCUITS STILL MANUFACTURED TODAY WITHIN THE AIRLIFE PORTFOLIO, NONE OF THE REMAINING PRODUCTS HAVE A HEATED WIRE AND WICK DESIGN USED IN THE ANAPOD PRODUCT. GIVEN THE OBSOLESCENCE OF THIS DESIGN, THERE ARE NO CORRECTIVE ACTIONS OR MODIFICATION APPLICABLE TO THE REMAINING PRODUCTS. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.
SHORTLY AFTER CONNECTING THE ANAPOD HUMI-THERMHEATED AND HUMIDIFIED WICK BREATHING CIRCUIT DEVICE TO THE HELICOPTER OXYGEN AND THE ANAPOD TO THE HELICOPTER ELECTRIC OUTLET A FIRE WAS NOTED IN THE CIRCUIT. THE CIRCUIT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE HELICOPTER. THE PATIENT HAD SOOT IN THE NARES AND DEVELOPED IMMEDIATE RESPIRATORY DISTRESS. THE PATIENT WAS INTUBATED AND WAS FOUND TO HAVE BURNS IN THE NARES.
SHORTLY AFTER CONNECTING THE ANAPOD HUMI-THERMHEATED AND HUMIDIFIED WICK BREATHING CIRCUIT DEVICE TO THE HELICOPTER OXYGEN AND THE ANAPOD TO THE HELICOPTER ELECTRIC OUTLET A FIRE WAS NOTED IN THE CIRCUIT. THE CIRCUIT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE HELICOPTER. THE PATIENT HAD SOOT IN THE NARES AND DEVELOPED IMMEDIATE RESPIRATORY DISTRESS. THE PATIENT WAS INTUBATED AND WAS FOUND TO HAVE BURNS IN THE NARES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2688863 | WESTMED LLC | ANAPOD HUMI-THERM WICK TRANSPORT CIRCUIT, 48", 28V | CAI | WESTMED LLC | A9244, A2003-1 | 112321T96 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |