HEMOLUNG CR4 CONTROLLER
Report
- Report Number
- 3009763347-2018-00001
- Event Type
- Malfunction
- Date Received
- March 8, 2018
- Date of Event
- December 20, 2017
- Report Date
- March 8, 2018
- Manufacturer
- ALUNG TECHNOLOGIES, INC
- Product Code
- DQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
WHILE PRIMING THIS CONTROLLER FOR A NEW PATIENT, THE USER EXPERIENCED A SOFTWARE BUG THAT PLACED THE DEVICE INTO A CONTINUOUS PRIMING LOOP NOT ALLOWING FOR THE PUMP TO START. THE POWER WAS CYCLED IN ATTEMPT TO RESET THE DEVICE. THIS WAS UNSUCCESSFUL. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. AT THIS TIME, NO PATIENT ISSUES WERE REPORTED. ALUNG IS TAKING THE FOLLOWING ACTIONS: COMMUNICATE TO HOSPITAL TO DISCONTINUE USE OF THE DEVICE. COMPLETED. ALUNG IS ACTIVELY COLLECTING DEVICE DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. COMPLETED. COMPLETE FINAL ANALYSIS OF THE EVENT. COMPLETED. FOLLOW-UP 02-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND IS CURRENTLY RETREIVING THE DEVICE FOR ANALSYSIS. THE DEVICE IS EXPECTED BACK FOR ANALYSIS BY 2-22-2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. FOLLOW-UP 03-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND RETRIEVED THE DEVICE FOR ANALYSIS. THE DEVICE ANALYSIS IS EXPECTED TO BE COMPLETED BY 04/01/2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. FOLLOW UP 04-18-18: DURING DEVICE ANALYSIS, IT WAS DISCOVERED THERE IS AN ISSUE WITH THE E-STOP SWITCH (ERROR CODE 125). THE SERVICING ASSOCIATED WITH THIS FAILURE IS STILL IN-PROGRESS. IT SHOULD BE NOTED THAT THIS ISSUE HAS NO IMPACT ON THE SOFTWARE ISSUE THAT RESULTED IN THE DEVICE BEING PLACED INTO A CONTINUOUS LOOP AND THE PUMP NOT STARTING FOR THERAPY. THE RECIRCULATION ISSUE WILL BE CORRECTED IN A NEW SOFTWARE RELEASE (4.1.2.HU) THAT IS PLANNED FOR JUNE 2018. AFTER COMPLETION OF THE FINAL ANALYSIS OF THE DEVICE AND SOFTWARE UPDATE, ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT FINAL REPORT 06-19-18: .WHILE PRIMING THE CR4 CONTROLLER FOR A NEW PATIENT, THE USER EXPERIENCED A SOFTWARE BUG THAT PLACED THE DEVICE INTO A CONTINUOUS PRIMING LOOP NOT ALLOWING FOR THE PUMP TO START. THE POWER WAS CYCLED IN ATTEMPT TO RESET THE DEVICE. THIS WAS UNSUCCESSFUL. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. THERE WERE NO PATIENT ISSUES REPORTED. DURING DEVICE ANALYSIS, IT WAS DISCOVERED THERE WAS AN ISSUE WITH THE E-STOP SWITCH (ERROR CODE 125). THE SERVICING ASSOCIATED WITH THIS FAILURE HAS BEEN COMPLETED BY REPLACING THE CONTROLLER BOARD. IT SHOULD BE NOTED THAT THIS ISSUE HAS NO IMPACT ON THE SOFTWARE ISSUE THAT RESULTED IN THE DEVICE BEING PLACED INTO A CONTINUOUS LOOP AND THE PUMP NOT STARTING FOR THERAPY. THE RECIRCULATION ISSUE WAS CORRECTED IN A NEW SOFTWARE RELEASE (4.1.1.HU) THAT WAS UPGRADED ON THIS CONTROLLER. IT SHOULD BE NOTED THERE WAS AN ERROR IN THE FOLLOW UP REPORT SENT ON 04/18/18. THE SOFTWARE VERSION THAT CORRECTED THE BUG IS 4.1.1HU, NOT 4.1.2HU AS NOTED IN THAT REPORT. THIS CONTROLLER HAS PASSED ALL TESTS, AND ANNUAL MAINTENANCE WAS CONDUCTED SUCCESSFULLY. IT IS SUITABLE FOR USE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ATTACHMENT: [(B)(4) REPORTS.ZIP]
WHILE PRIMING THIS CONTROLLER FOR A NEW PATIENT, THE USER EXPERIENCED A SOFTWARE BUG THAT PLACED THE DEVICE INTO A CONTINUOUS PRIMING LOOP NOT ALLOWING FOR THE PUMP TO START. THE POWER WAS CYCLED IN ATTEMPT TO RESET THE DEVICE. THIS WAS UNSUCCESSFUL. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. AT THIS TIME, NO PATIENT ISSUES WERE REPORTED. ALUNG IS TAKING THE FOLLOWING ACTIONS: 1. COMMUNICATE TO HOSPITAL TO DISCONTINUE USE OF THE DEVICE. COMPLETED. 2. ALUNG IS ACTIVELY COLLECTING DEVICE DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. COMPLETED. 3. COMPLETE FINAL ANALYSIS OF THE EVENT. FOLLOW-UP 02-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND IS CURRENTLY RETREIVING THE DEVICE FOR ANALSYSIS. THE DEVICE IS EXPECTED BACK FOR ANALYSIS BY 2-22-2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. FOLLOW-UP 03-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND RETRIEVED THE DEVICE FOR ANALYSIS. THE DEVICE ANALYSIS IS EXPECTED TO BE COMPLETED BY 04/01/2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. (B)(4).
PER THE TREATING PHYSICIAN, AFTER PREPARATION OF THE HEMOLUNG CONTROLLER AND PRIMING OF THE CIRCUIT WITHOUT DIFFICULTY, THERAPY WAS UNABLE TO INITIATED AFTER CONNECTION OF THE BLOOD TUBING TO THE HEMOLUNG CATHETER. THE PRIMING SCREENS CONTINUED AFTER PATIENT CONNECTION WITHOUT THE ABILITY TO PROCEED TO PUMP START. NO ALARMS WERE PRESENT. AFTER POWER CYCLING THE CONTROLLER, THERAPY WAS STILL UNABLE TO BE INITIATED. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. NO PATIENT IMPACT WAS REPORTED.
PER THE TREATING PHYSICIAN, AFTER PREPARATION OF THE HEMOLUNG CONTROLLER AND PRIMING OF THE CIRCUIT WITHOUT DIFFICULTY, THERAPY WAS UNABLE TO INITIATED AFTER CONNECTION OF THE BLOOD TUBING TO THE HEMOLUNG CATHETER. THE PRIMING SCREENS CONTINUED AFTER PATIENT CONNECTION WITHOUT THE ABILITY TO PROCEED TO PUMP START. NO ALARMS WERE PRESENT. AFTER POWER CYCLING THE CONTROLLER, THERAPY WAS STILL UNABLE TO BE INITIATED. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. NO PATIENT IMPACT WAS REPORTED.
WHILE PRIMING THIS CONTROLLER FOR A NEW PATIENT, THE USER EXPERIENCED A SOFTWARE BUG THAT PLACED THE DEVICE INTO A CONTINUOUS PRIMING LOOP NOT ALLOWING FOR THE PUMP TO START. THE POWER WAS CYCLED IN ATTEMPT TO RESET THE DEVICE. THIS WAS UNSUCCESSFUL. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. AT THIS TIME, NO PATIENT ISSUES WERE REPORTED. ALUNG IS TAKING THE FOLLOWING ACTIONS: COMMUNICATE TO HOSPITAL TO DISCONTINUE USE OF THE DEVICE. COMPLETED ALUNG IS ACTIVELY COLLECTING DEVICE DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. COMPLETE FINAL ANALYSIS OF THE EVENT. FOLLOW-UP 02-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND IS CURRENTLY RETRIEVING THE DEVICE FOR ANALYSIS. THE DEVICE IS EXPECTED BACK FOR ANALYSIS BY 2-22-2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. - (B)(4)
WHILE PRIMING THIS CONTROLLER FOR A NEW PATIENT, THE USER EXPERIENCED A SOFTWARE BUG THAT PLACED THE DEVICE INTO A CONTINUOUS PRIMING LOOP NOT ALLOWING FOR THE PUMP TO START. THE POWER WAS CYCLED IN ATTEMPT TO RESET THE DEVICE. THIS WAS UNSUCCESSFUL. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. AT THIS TIME, NO PATIENT ISSUES WERE REPORTED. ALUNG IS TAKING THE FOLLOWING ACTIONS: COMMUNICATE TO HOSPITAL TO DISCONTINUE USE OF THE DEVICE. COMPLETED ALUNG IS ACTIVELY COLLECTING DEVICE DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. COMPLETED. COMPLETE FINAL ANALYSIS OF THE EVENT. FOLLOW-UP 02-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND IS CURRENTLY RETREIVING THE DEVICE FOR ANALSYSIS. THE DEVICE IS EXPECTED BACK FOR ANALYSIS BY 2-22-2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. FOLLOW-UP 03-19-2018: ALUNG HAS COMPLETED THE COMMUNICATION TO THE HOSPITAL AND RETRIEVED THE DEVICE FOR ANALYSIS. THE DEVICE ANALYSIS IS EXPECTED TO BE COMPLETED BY 04/01/2018. AFTER COMPLETION OF THE DEVICE ANALYSIS ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. FOLLOW UP 04-18-18: DURING DEVICE ANALYSIS, IT WAS DISCOVERED THERE IS AN ISSUE WITH THE E-STOP SWITCH (ERROR CODE 125). THE SERVICING ASSOCIATED WITH THIS FAILURE IS STILL IN-PROGRESS. IT SHOULD BE NOTED THAT THIS ISSUE HAS NO IMPACT ON THE SOFTWARE ISSUE THAT RESULTED IN THE DEVICE BEING PLACED INTO A CONTINUOUS LOOP AND THE PUMP NOT STARTING FOR THERAPY. THE RECIRCULATION ISSUE WILL BE CORRECTED IN A NEW SOFTWARE RELEASE (4.1.2.HU) THAT IS PLANNED FOR JUNE 2018. AFTER COMPLETION OF THE FINAL ANALYSIS OF THE DEVICE AND SOFTWARE UPDATE, ALUNG WILL PROVIDE AN UPDATE TO THIS INCIDENT REPORT. (B)(4).
PER THE TREATING PHYSICIAN, AFTER PREPARATION OF THE HEMOLUNG CONTROLLER AND PRIMING OF THE CIRCUIT WITHOUT DIFFICULTY, THERAPY WAS UNABLE TO INITIATED AFTER CONNECTION OF THE BLOOD TUBING TO THE HEMOLUNG CATHETER. THE PRIMING SCREENS CONTINUED AFTER PATIENT CONNECTION WITHOUT THE ABILITY TO PROCEED TO PUMP START. NO ALARMS WERE PRESENT. AFTER POWER CYCLING THE CONTROLLER, THERAPY WAS STILL UNABLE TO BE INITIATED. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. NO PATIENT IMPACT WAS REPORTED.
PER THE TREATING PHYSICIAN, AFTER PREPARATION OF THE HEMOLUNG CONTROLLER AND PRIMING OF THE CIRCUIT WITHOUT DIFFICULTY, THERAPY WAS UNABLE TO INITIATED AFTER CONNECTION OF THE BLOOD TUBING TO THE HEMOLUNG CATHETER. THE PRIMING SCREENS CONTINUED AFTER PATIENT CONNECTION WITHOUT THE ABILITY TO PROCEED TO PUMP START. NO ALARMS WERE PRESENT. AFTER POWER CYCLING THE CONTROLLER, THERAPY WAS STILL UNABLE TO BE INITIATED. THE CIRCUIT WAS DISCONNECTED AND THE CATHETER WAS REMOVED. NO PATIENT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167895 | HEMOLUNG CR4 CONTROLLER | HEMOLUNG CR4 CONTROLLER | DQR | ALUNG TECHNOLOGIES, INC | REF 21000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |