LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2022-02085
- Event Type
- Malfunction
- Date Received
- December 5, 2022
- Date of Event
- November 30, 2022
- Report Date
- May 17, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED WITH NO PHYSICAL DAMAGE NOTED. ALTHOUGH THERE WAS EVIDENCE OF DRIED FLUID PRESENT WITHIN THE CASSETTE COMPARTMENT, THERE WERE NO VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA, AND NO BURRS OR SHARP EDGES IN THE CASSETTE AREA THAT COULD HAVE PUNCTURED THE CASSETTE MEMBRANE. A PATIENT SENSORS TEST WAS PERFORMED AND PASSED. A VALVE ACTUATION TEST, SYSTEM AIR LEAK TEST, AND TEACH PUMPS CHECK WERE PERFORMED AND PASSED. A POST-ACCELERATED STRESS TEST (AST) 2HOURS 15MINS 8500ML SIMULATED TREATMENT WAS PERFORMED WITHOUT ANY FAILURES OR PROBLEMS. THERE WERE NO FLUID LEAKS IN THE TEST CASSETTE DURING THE ACCELERATED STRESS TEST. A MUSHROOM HEAD CHECK WAS PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION IDENTIFIED EVIDENCE OF DRIED FLUID UNDER THE PUMP ASSEMBLY ON THE BOTTOM COVER AND FLUID IN THE HP2 FILTER, WHICH IS A RELATED FAILURE TO THE M31 AIR DETECTED IN CASSETTE WARNING ALARM. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FLUID LEAK EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. WHEN THE CYCLER IS RETURNED AND NEW INFORMATION IS AVAILABLE, THE COMPLAINT INVESTIGATION WILL BE UPDATED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 1 OF 9. THE WARNING OCCURRED THREE NIGHTS (QSN #(B)(4)). THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS DISCOVERED. THE CAUSE AND SOURCE OF THE LEAK ARE UNKNOWN. TECHNICAL SUPPORT ISSUED A REPLACEMENT CYCLER DUE TO THE M31 AIR DETECTED IN CASSETTE ALARM EVEN AFTER RE-SETUP WITH NEW SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM THEM OF THE REPLACEMENT. THE PATIENT WILL NOT PERFORM MANUAL TREATMENT AS THEY DO NOT KNOW HOW TO. UPON FOLLOWUP ON (B)(6) 2022, THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THEY HAD NOT BEEN MADE AWARE OF THE REPORTED EVENT BY THE PATIENT. THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN COULD NOT CONFIRM IF THE NEW CYCLER HAS BEEN RECEIVED, OR THE PREVIOUS ONE RETURNED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 1 OF 9. THE WARNING OCCURRED THREE NIGHTS (QSN #(B)(6)). THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS DISCOVERED. THE CAUSE AND SOURCE OF THE LEAK ARE UNKNOWN. TECHNICAL SUPPORT ISSUED A REPLACEMENT CYCLER DUE TO THE M31 AIR DETECTED IN CASSETTE ALARM EVEN AFTER RE-SETUP WITH NEW SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM THEM OF THE REPLACEMENT. THE PATIENT WILL NOT PERFORM MANUAL TREATMENT AS THEY DO NOT KNOW HOW TO. UPON FOLLOWUP ON 12/05/2022, THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THEY HAD NOT BEEN MADE AWARE OF THE REPORTED EVENT BY THE PATIENT. THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN COULD NOT CONFIRM IF THE NEW CYCLER HAS BEEN RECEIVED, OR THE PREVIOUS ONE RETURNED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 1 OF 9. THE WARNING OCCURRED THREE NIGHTS (QSN #8013357245, 8013361985, 8013352444). THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS DISCOVERED. THE CAUSE AND SOURCE OF THE LEAK ARE UNKNOWN. TECHNICAL SUPPORT ISSUED A REPLACEMENT CYCLER DUE TO THE M31 AIR DETECTED IN CASSETTE ALARM EVEN AFTER RE-SETUP WITH NEW SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM THEM OF THE REPLACEMENT. THE PATIENT WILL NOT PERFORM MANUAL TREATMENT AS THEY DO NOT KNOW HOW TO. UPON FOLLOWUP ON 12/05/2022, THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THEY HAD NOT BEEN MADE AWARE OF THE REPORTED EVENT BY THE PATIENT. THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN COULD NOT CONFIRM IF THE NEW CYCLER HAS BEEN RECEIVED, OR THE PREVIOUS ONE RETURNED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1358483 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | DELFLEX PD SOLUTION| DELFLEX PD SOLUTION| DELFLEX PD SOLUTION| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET |