LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 2937457-2021-00700
- Event Type
- Malfunction
- Date Received
- April 19, 2021
- Date of Event
- April 14, 2021
- Report Date
- July 26, 2021
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
CORRECTION G4 PMA/510(K)#: K181108.
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE TOP COVER. THERE WERE NO VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. 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 CYCLER UNDERWENT AND PASSED A SYSTEM AIR LEAK TEST, PATIENT PRESSURE SENSOR CALIBRATION CHECK AND A VALVE ACTUATION TEST. THE MUSHROOM HEAD CHECKS PASSED. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER UNDERNEATH THE PUMP ASSEMBLY. 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 EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.
ADDITIONAL INFORMATION: G2 CORRECTION: THE H6 HEALTH EFFECT WAS INADVERTENTLY SUBMITTED IN INITIAL AS C50675-NO HEALTH CONSEQUENCES OR IMPACT, HOWEVER THE CORRECT H6 HEALTH EFFECT IS C172008-MINOR INJURY/ ILLNESS / IMPAIRMENT.
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 FOLLOWING THE PATIENT CONTACT¿S REPORT THAT DURING TREATMENT THE PATIENT WAS IN PAIN AFTER CYCLE 2 OF TREATMENT. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 5491 ML DURING DRAIN NUMBER TWO OF TREATMENT. THIS DRAIN VOLUME IS 219% THE PATIENT'S LARGEST FILL VOLUME OF 2508 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, THE PATIENT¿S 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 BY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. 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. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS FOLLOWING THE PATIENT CONTACT¿S REPORT THAT DURING TREATMENT THE PATIENT WAS IN PAIN AFTER CYCLE 2 OF TREATMENT. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 5491 ML DURING DRAIN NUMBER TWO OF TREATMENT. THIS DRAIN VOLUME IS 219% THE PATIENT'S LARGEST FILL VOLUME OF 2508 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, THE PATIENT¿S 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 BY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. 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. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS FOLLOWING THE PATIENT CONTACT¿S REPORT THAT DURING TREATMENT THE PATIENT WAS IN PAIN AFTER CYCLE 2 OF TREATMENT. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 5491 ML DURING DRAIN NUMBER TWO OF TREATMENT. THIS DRAIN VOLUME IS 219% THE PATIENT'S LARGEST FILL VOLUME OF 2508 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, THE PATIENT¿S 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 BY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. THE CYCLER WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
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 FOLLOWING THE PATIENT CONTACT¿S REPORT THAT DURING TREATMENT THE PATIENT WAS IN PAIN AFTER CYCLE 2 OF TREATMENT. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 5491 ML DURING DRAIN NUMBER TWO OF TREATMENT. THIS DRAIN VOLUME IS 219% THE PATIENT'S LARGEST FILL VOLUME OF 2508 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, THE PATIENT¿S 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 BY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 584729 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET |