LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 2937457-2022-00472
- Event Type
- Malfunction
- Date Received
- March 25, 2022
- Date of Event
- March 6, 2022
- Report Date
- May 11, 2022
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
H.3 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE. ALTHOUGH THERE WAS EVIDENCE OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP DOOR AND ON THE TOP COVER, THERE WERE NO BURRS OR SHARP EDGES IN THE CASSETTE AREA THAT COULD HAVE PUNCTURED THE CASSETTE MEMBRANE. THERE WERE VISUAL INDICATIONS OF PARTICULATES AROUND THE CATCH POST AREA AND WITHIN CASSETTE COMPARTMENT. AN ACCELERATED STRESS TEST (AST) WAS PERFORMED ON THE CYCLER AND TREATMENT STOPPED DURING STEP 2. SYMPTOM CODE M01-17 CANNOT TEACH PUMPS DURING SETUP PHASE OCCURRED. THE CAUSE WAS IDENTIFIED AS AN I/O BOARD; PUMP MOTOR B FAILED AND STALLED DURING TESTING. A GOOD I/O BOARD WAS INSTALLED, AND THE PUMP MOTOR B BECAME OPERATIONAL. A SECOND AST SIMULATED TREATMENT WAS COMPLETED WITHOUT ANY FAILURES. AN INVESTIGATION OF THE CYCLER MUSHROOM HEADS VERIFIED THAT THE SURFACE CONDITIONS AND ALIGNMENTS WERE WITHIN SPECIFICATION. THERE WERE VISUAL INDICATIONS OF DRIED FLUID BETWEEN THE PUMP ASSEMBLY AND DISPLAY ASSEMBLY FOUND DURING INTERNAL INSPECTION. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. THERE WAS VISUAL EVIDENCE OF A CLOG IN THE HP2 FILTER, RELATED TO THE REPORTED M31 AIR DETECTED IN CASSETTE WARNING. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. 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 EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
CORRECTED INFORMATION: B.5.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF TREATMENT AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THE CYCLER SET CASSETTE FILM RUPTURED DUE TO MASS AMOUNTS OF AIR. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. UPON FOLLOW UP, THE PDRN STATED THE PATIENT HAS BEEN SCHEDULED FOR TRAINING ON MANUAL PERITONEAL DIALYSIS THERAPY PERFORMING STAT DRAINS AND CONFIRMED THAT THE PATIENT WAS UNABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF TREATMENT AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THE CYCLER SET CASSETTE FILM RUPTURED DUE TO MASS AMOUNTS OF AIR. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. UPON FOLLOW UP, THE PDRN STATED THE PATIENT HAS BEEN SCHEDULED FOR TRAINING ON MANUAL PERITONEAL DIALYSIS THERAPY PERFORMING STAT DRAINS AND CONFIRMED THAT THE PATIENT WAS UNABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF TREATMEN. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THE CYCLER SET CASSETTE FILM RUPTURED DUE TO MASS AMOUNTS OF AIR. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. UPON FOLLOW UP, THE PDRN STATED THE PATIENT HAS BEEN SCHEDULED FOR TRAINING ON MANUAL PERITONEAL DIALYSIS THERAPY PERFORMING STAT DRAINS AND CONFIRMED THAT THE PATIENT WAS UNABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 885468 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET | LIBERTY CYCLER SET | LIBERTY CYCLER SET |