LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
Report
- Report Number
- 0008030665-2026-00354
- Event Type
- Malfunction
- Date Received
- February 18, 2026
- Date of Event
- February 14, 2026
- Report Date
- April 30, 2026
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- UDI-DI
- 00840861100750
- PMA / PMN Number
- K173718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE PATIENT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS SETS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANACES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A PERITONEAL DIALYSIS (PD) PATIENT CONTACT STATED AFTER NOTICING THE FLUID THEY WERE NOT ABLE TO CLOSE THE CASSETTE DOOR (THEY HAD PRESSED NEXT). THEY REBOOTED THE CYCLER AND ENCOUNTERED A MWD WATCHDOG TIMER ERROR ALARM. A FLUID LEAK WAS NOTICED WHEN REMOVING THE CASSETTE ON STEP 9 OF TREATMENT. THE PATIENT WAS CONNECTED DURING INCIDENT AND FLUID WAS FOUND ON THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR. NO ALARM WAS NOTED PRIOR TO THE FLUID LEAK. THE CONTACT STATED THE CASSETTE/TUBING DID NOT LOOK LIKE IT HAD ANY HOLES OR TEARS IN IT. THE MWD - WATCHDOG TIMER ERROR ALARM OCCURRED TWICE ON POWER UP. THE CONTACT ALSO NEEDED HELP WITH HOW TO GET THE CASSETTE DOOR TO CLOSE SINCE DOOR WAS STILL OPEN. THE CYCLER WAS REBOOTED AND THE PATIENT ALSO DISCONNECTED AND RECONNECTED THE POWER CORD AND THE ALARM CLEARED. THE PATIENT WAS ABLE TO CLOSE THE DOOR ON THE READY SCREEN AND WAS ADVISED TO WAIT 1 DAY BEFORE USING THE CYCLER AGAIN. THE CONTACT WAS ASKING IF THEY COULD CONTINUE USING CYCLER TONIGHT AND WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW-UP, THE PDRN STATED A FLUID LEAK WAS DISCOVERED DURING STEP 9 - END OF TREATMENT AFTER TREATMENT WAS COMPLETED AND WHEN THE PATIENT CONTACT OPENED THE CASSETTE DOOR. THE CASSETTE DOOR WAS OPENED AND FLUID WAS DISCOVERED LEAKING FROM THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR, IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE FILM ON THE BACK OF THE CASSETTE APPEARED INTACT AND THE FLUID LEAKED FROM AN UNKNOWN LOCATION. THE PATIENT WAS ABLE TO REVERT TO MANUALS TO COMPLETE TREATMENT ON THE NIGHT OF THE REPORTED EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PDRN ALLOWED FOR THE CYCLER CASSETTE AREA TO DRY AND HAS RESUMED TREATMENT USING THE CYCLER WITHOUT FURTHER ISSUE. THE PDRN STATED THE CYCLER SET (CASSETTE) USED WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR INVESTIGATION.
A PERITONEAL DIALYSIS (PD) PATIENT CONTACT STATED AFTER NOTICING THE FLUID THEY WERE NOT ABLE TO CLOSE THE CASSETTE DOOR (THEY HAD PRESSED NEXT). THEY REBOOTED THE CYCLER AND ENCOUNTERED A MWD WATCHDOG TIMER ERROR ALARM. A FLUID LEAK WAS NOTICED WHEN REMOVING THE CASSETTE ON STEP 9 OF TREATMENT. THE PATIENT WAS CONNECTED DURING INCIDENT AND FLUID WAS FOUND ON THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR. NO ALARM WAS NOTED PRIOR TO THE FLUID LEAK. THE CONTACT STATED THE CASSETTE/TUBING DID NOT LOOK LIKE IT HAD ANY HOLES OR TEARS IN IT. THE MWD - WATCHDOG TIMER ERROR ALARM OCCURRED TWICE ON POWER UP. THE CONTACT ALSO NEEDED HELP WITH HOW TO GET THE CASSETTE DOOR TO CLOSE SINCE DOOR WAS STILL OPEN. THE CYCLER WAS REBOOTED AND THE PATIENT ALSO DISCONNECTED AND RECONNECTED THE POWER CORD AND THE ALARM CLEARED. THE PATIENT WAS ABLE TO CLOSE THE DOOR ON THE READY SCREEN AND WAS ADVISED TO WAIT 1 DAY BEFORE USING THE CYCLER AGAIN. THE CONTACT WAS ASKING IF THEY COULD CONTINUE USING CYCLER TONIGHT AND WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW-UP, THE PDRN STATED A FLUID LEAK WAS DISCOVERED DURING STEP 9 - END OF TREATMENT AFTER TREATMENT WAS COMPLETED AND WHEN THE PATIENT CONTACT OPENED THE CASSETTE DOOR. THE CASSETTE DOOR WAS OPENED AND FLUID WAS DISCOVERED LEAKING FROM THE BOTTOM RIGHT INSIDE OF THE CASSETTE DOOR, IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE FILM ON THE BACK OF THE CASSETTE APPEARED INTACT AND THE FLUID LEAKED FROM AN UNKNOWN LOCATION. THE PATIENT WAS ABLE TO REVERT TO MANUALS TO COMPLETE TREATMENT ON THE NIGHT OF THE REPORTED EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PDRN ALLOWED FOR THE CYCLER CASSETTE AREA TO DRY AND HAS RESUMED TREATMENT USING THE CYCLER WITHOUT FURTHER ISSUE. THE PDRN STATED THE CYCLER SET (CASSETTE) USED WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321623 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | ERIKA DE REYNOSA, S.A. DE C.V. | 00840861100750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |