HEMOLUNG RAS
Report
- Report Number
- 3009763347-2018-00002
- Event Type
- Malfunction
- Date Received
- March 19, 2018
- Date of Event
- February 21, 2018
- Report Date
- March 19, 2018
- Manufacturer
- ALUNG TECHNOLOGIES, INC
- Product Code
- DQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPTING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN. ALUNG IS TAKING THE FOLLOWING ACTIONS: 1. ALUNG IS ACTIVELY COLLECTING DEVICE DATA AND PATIENT DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. 2. COMPLETE FINAL ANALYSIS OF THE EVENT. FOLLOW UP 04-18-18: ALUNG HAS COLLECTED DEVICE DATA AND RETRIEVED THE DEVICE FROM THE HOSPITAL FOR INSPECTION AND SERVICING. ALUNG IS CONTINUING TO ATTEMPT TO COLLECT PATIENT DATA. FOLLOW UP 05-17-18: THE CR4 DEVICE WAS INSPECTED AT INSIGHT DYNAMICS AND IT WAS DETERMINED THERE WERE OXYGEN LEAKS IN THE GAS MODULE. IT WAS FOUND THAT THE LEAK OCCURRED IN THE TUBING CONNECTIONS ON TWO OF THE VACUUM PUMP OUTPUT. THE TY WRAPS CANNOT CLOSE THE GAP BETWEEN THE STUD AND THE TUBING COMPLETELY. THE TUBING WILL BE REPLACED AND THE CR4 CONTROLLER WILL BE TESTED TO ENSURE IT IS OPERATING AS INTENDED. ALUNG WAS UNSUCCESSFUL IN COLLECTING PATIENT DATA FROM THE TREATING PHYSICIAN. ALUNG MADE A GOOD FAITH ATTEMPT TO COLLECT THIS DATA, BUT WITH INTERNAL BUSINESS DECISIONS IMPACTING FRANCE IT IS BELIEVED THAT THE SITE WISHES TO NO LONGER COMMUNICATE WITH ALUNG FINAL REPORT 06/15/18: ALUNG'S DEVICE ANALYSIS RESULTS: ALUNG WAS NOTIFIED OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED DURING THERAPY. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AT THAT TIME. ALUNG WAS UNSUCCESSFUL IN COLLECTING PATIENT DATA FROM THE TREATING PHYSICIAN. ALUNG MADE A GOOD FAITH ATTEMPT TO COLLECT THIS DATA, BUT WITH INTERNAL BUSINESS DECISIONS IMPACTING FRANCE IT IS BELIEVED THAT THE SITE WISHES TO NO LONGER COMMUNICATE WITH ALUNG. THE CR4 DEVICE WAS INSPECTED AT INSIGHT DYNAMICS AND IT WAS DETERMINED THERE WERE OXYGEN LEAKS IN THE GAS MODULE. IT WAS FOUND THAT THE LEAK OCCURRED IN THE TUBING CONNECTIONS ON TWO OF THE VACUUM PUMP OUTPUT. THE TY WRAPS CANNOT CLOSE THE GAP BETWEEN THE STUD AND THE TUBING COMPLETELY. THE TUBING WAS FIXED TO BE MORE SECURE TO INPUTS AND OUTPUTS OF THE VACUUM PUMP. THE OXYGEN SENSOR, NAFION TUBING, AND CO2 TUBING WERE ALL REPLACED, AND THE CONTROLLER WAS TESTED TO ENSURE IT WAS WORKING AS EXPECTED. THE CONTROLLER PASSED ALL THE TESTS, AND IS SUITABLE FOR USE. ALUNG WILL CONTINUE TO MONITOR THE OCCURRENCE OF ERROR CODE 108. TO DATE, THIS IS THE FIRST REPORTED OCCURRENCE OF THIS SPECIFIC ERROR. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ATTACHMENT: [{INITIAL REPORT}-EMDR - FRANCE ZIPPED FILES.ZIP, CASE (B)(4) FINAL REPORT - ALUNG TECHNOLOGIES 06-15-18_SIGNED.PDF].
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN. ALUNG IS TAKING THE FOLLOWING ACTIONS: 1. ALUNG IS ACTIVELY COLLECTING DEVICE DATA AND PATIENT DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. 2. COMPLETE FINAL ANALYSIS OF THE EVENT. FOLLOW UP 04-18-18: ALUNG HAS COLLECTED DEVICE DATA AND RETRIEVED THE DEVICE FROM THE HOSPITAL FOR INSPECTION AND SERVICING. ALUNG IS CONTINUING TO ATTEMPT TO COLLECT PATIENT DATA. FOLLOW UP 05-17-18: THE CR4 DEVICE WAS INSPECTED AT INSIGHT DYNAMICS AND IT WAS DETERMINED THERE WERE OXYGEN LEAKS IN THE GAS MODULE. IT WAS FOUND THAT THE LEAK OCCURRED IN THE TUBING CONNECTIONS ON TWO OF THE VACUUM PUMP OUTPUT. THE TY WRAPS CANNOT CLOSE THE GAP BETWEEN THE STUD AND THE TUBING COMPLETELY. THE TUBING WILL BE REPLACED AND THE CR4 CONTROLLER WILL BE TESTED TO ENSURE IT IS OPERATING AS INTENDED.ALUNG WAS UNSUCCESSFUL IN COLLECTING PATIENT DATA FROM THE TREATING PHYSICIAN. ALUNG MADE A GOOD FAITH ATTEMPT TO COLLECT THIS DATA, BUT WITH INTERNAL BUSINESS DECISIONS IMPACTING FRANCE IT IS BELIEVED THAT THE SITE WISHES TO NO LONGER COMMUNICATE WITH ALUNG -
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPTING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN.
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN.
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPTING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN. ALUNG IS TAKING THE FOLLOWING ACTIONS: ALUNG IS ACTIVELY COLLECTING DEVICE DATA AND PATIENT DATA IN REGARDS TO THIS EVENT. THE DEVICE WILL BE REMOVED FROM THE HOSPITAL FOR INSPECTION AND SERVICING. COMPLETE FINAL ANALYSIS OF THE EVENT.
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPTING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN. ALUNG IS TAKING THE FOLLOWING ACTIONS: ALUNG IS ACTIVELY COLLECTING DEVICE DATA AND PATIENT 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 04-18-18: ALUNG HAS COLLECTED DEVICE DATA AND RETRIEVED THE DEVICE FROM THE HOSPITAL FOR INSPECTION AND SERVICING. ALUNG IS CONTINUING TO ATTEMPT TO COLLECT PATIENT DATA. (B)(4).
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN.
ALUNG HAS BECAME AWARE OF AN INTERRUPTION OF THERAPY IN WHICH THE PUMP STOPPED. ERROR CODE 108 WAS REPORTED BY THE SITE. THIS ERROR CODE EQUATES TO CABINET OXYGEN SENSOR FAILURE, WHICH CAUSES THE PUMP TO STOP. THE PHYSICIAN DID NOT REPORT ANY PATIENT IMPACT AND WE ARE ATTEMPTING TO COLLECT MORE INFORMATION WITH THE TREATING PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194106 | HEMOLUNG RAS | HEMOLUNG RAS | DQR | ALUNG TECHNOLOGIES, INC | REF 21000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |