LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2024-00444
- Event Type
- Malfunction
- Date Received
- March 17, 2024
- Date of Event
- February 28, 2024
- Report Date
- July 16, 2024
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL ANALYSIS. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE NO VISUAL INDICATION OF PARTICULATES WITHIN THE CASSETTE COMPARTMENT. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. AN (AS-RECEIVED) SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT FAILURES. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE FOR A LIBERTY CYCLER. THE DRAIN TIMES WERE WITHIN THE TIME SPECIFICATIONS FOR A LIBERTY CYCLER PER (P/N 180069). NO FLUID LEAKS IN THE TEST CASSETTE DURING THE TREATMENT TEST. SYSTEM AIR LEAK TEST PASSED. VALVE ACTUATION TEST PASSED. THE INTERNAL INSPECTION OF THE CYCLER SHOWED THAT THERE WERE INDICATIONS OF DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE ENCOUNTERED DRIED FLUID COULD NOT BE DETERMINED. MUSHROOM HEAD CHECK PASSED. THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ISSUES OR PROBLEMS RELATED TO THE REPORTED SYMPTOM CODE(S).UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
CORRECTION: B.3., D.8., AND D.10.
THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS WHEN PATIENT HAD CALLED INTO TECHNICAL SERVICES DUE TO AN UNKNOWN DRAIN ALARM. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 3627 ML DURING DRAIN 3 OF THE TREATMENT. THIS DRAIN VOLUME IS 181% OF THE PATIENT'S PRESCRIBED FILL VOLUME OF 2000 ML. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. UPON FOLLOW UP WITH THE PATIENT, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD).THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. THE CYCLER WAS REPORTED TO BE RETURNED 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. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS WHEN PATIENT HAD CALLED INTO TECHNICAL SERVICES DUE TO AN UNKNOWN DRAIN ALARM. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 3627 ML DURING DRAIN 3 OF THE TREATMENT. THIS DRAIN VOLUME IS 181% OF THE PATIENT'S PRESCRIBED FILL VOLUME OF 2000 ML. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. UPON FOLLOW UP WITH THE PATIENT, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD).THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. THE CYCLER WAS REPORTED TO BE RETURNED 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. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS WHEN PATIENT HAD CALLED INTO TECHNICAL SERVICES DUE TO AN UNKNOWN DRAIN ALARM. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 3627 ML DURING DRAIN 3 OF THE TREATMENT. THIS DRAIN VOLUME IS 181% OF THE PATIENT'S PRESCRIBED FILL VOLUME OF 2000 ML. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. UPON FOLLOW UP WITH THE PATIENT, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD).THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. THE CYCLER WAS REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 965920 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET |