LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2024-00443
- Event Type
- Malfunction
- Date Received
- March 15, 2024
- Date of Event
- March 10, 2024
- Report Date
- April 29, 2024
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K222318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. AN (AS-RECEIVED) SIMULATED TREATMENT WAS PERFORMED AND COMPLETED. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE FOR A LIBERTY CYCLER. VALVE ACTUATION TEST PASSED. SYSTEM AIR LEAK TEST PASSED. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO DISCREPANCIES. 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 EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 4159 ML DURING DRAIN 4 OF 4 OF TREATMENT. THIS DRAIN VOLUME IS 189% THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME OF 2200 ML. AS A RESULT OF THE IIPV EVENT, A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN CONFIRMED THE PATIENT¿S TREATMENT WAS COMPLETED ON THE NIGHT OF THE REPORTED EVENT. THE PATIENT RESUMED USE OF THE CYCLER PENDING RECEIPT OF THE REPLACEMENT CYCLER. THE PATIENT WILL RECEIVE A NEW CYCLER AND WILL RESUME THERAPY USING THE NEW CYCLER UPON RECEIPT. THE CYCLER WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 4159 ML DURING DRAIN 4 OF 4 OF TREATMENT. THIS DRAIN VOLUME IS 189% THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME OF 2200 ML. AS A RESULT OF THE IIPV EVENT, A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN CONFIRMED THE PATIENT¿S TREATMENT WAS COMPLETED ON THE NIGHT OF THE REPORTED EVENT. THE PATIENT RESUMED USE OF THE CYCLER PENDING RECEIPT OF THE REPLACEMENT CYCLER. THE PATIENT WILL RECEIVE A NEW CYCLER AND WILL RESUME THERAPY USING THE NEW CYCLER UPON RECEIPT. THE CYCLER WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 966478 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | LIBERTY CYCLER SET| LIBERTY CYCLER SET| PD SOLUTION| PD SOLUTION |