LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2022-02169
- Event Type
- Injury
- Date Received
- December 19, 2022
- Date of Event
- October 24, 2022
- Report Date
- January 17, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN THE PATIENT¿S HOSPITALIZATION FOR FLUID VOLUME OVERLOAD AND REPORT OF DRAIN COMPLICATIONS DURING PD THERAPY WITH THE PD CATHETER (NOT A FRESENIUS PRODUCT) AND THE LIBERTY SELECT CYCLER. FLUID VOLUME OVERLOAD IS A COMMON COMPLICATION IN PATIENTS WITH END STAGE RENAL DISEASE (ESRD) ON DIALYSIS. THE PATIENT HAD CONCOMITANT CONSTIPATION. CONSTIPATION IS WELL DOCUMENTED TO IMPEDE DIALYSATE FLOW FROM THE PD CATHETER (NOT A FRESENIUS PRODUCT) WHICH CAN SUBSEQUENTLY LEAD TO FLUID VOLUME OVERLOAD IN PATIENTS ON PD THERAPY. CURRENTLY, THERE IS NO OBJECTIVE EVIDENCE THAT A LIBERTY SELECT CYCLER MALFUNCTION CAUSED THE PATIENT¿S FLUID OVERLOAD EVENT. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS LIKELY ATTRIBUTED TO THE PATIENT¿S CONCOMITANT CONDITION OF CONSTIPATION.
CORRECTION: B1.
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
ON (B)(6) 2022, A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT ON PD THERAPY WAS PREVIOUSLY HOSPITALIZED FOR FLUID RETENTION WITH REPORT OF CONSTIPATION. IN AN ADDITIONAL FOLLOW-UP CALL, THE CLINIC MANAGER CONFIRMED THAT THE PATIENT HAD BEEN HAVING ONGOING CONCOMITANT CONSTIPATION, PRIOR TO HOSPITALIZATION. IT WAS STATED THAT THE CONSTIPATION IMPEDED THE PATIENT¿S ABILITY TO DRAIN FROM THE PD CATHETER (NOT A FRESENIUS PRODUCT) DURING THE PD TREATMENT. AS A RESULT, ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED FOR FLUID VOLUME OVERLOAD. THE CLINIC MANAGER HAD LIMITED INFORMATION TO PROVIDE ABOUT THE HOSPITALIZATION AND THE DISCHARGE SUMMARY WAS NOT AVAILABLE. HOWEVER, IT WAS REPORTED THAT WHILE THE PATIENT WAS HOSPITALIZED, THEY RECEIVED DIALYSIS (TREATMENT DETAILS ARE UNKNOWN). ADDITIONALLY, THE PATIENT¿S CONSTIPATION WAS TREATED (DETAILS UNKNOWN). SUBSEQUENTLY, ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL CONTINUING PD TREATMENT ON THE FRESENIUS CYCLER. THE CLINIC MANAGER STATED THE HOSPITALIZATION FOR FLUID VOLUME OVERLOAD WAS LIKELY FROM THE PATIENT¿S CONCOMITANT CONSTIPATION WHICH WAS CAUSING ONGOING DRAIN COMPLICATIONS DURING THE PD TREATMENT.
ON (B)(6) 2022, A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT ON PD THERAPY WAS PREVIOUSLY HOSPITALIZED FOR FLUID RETENTION WITH REPORT OF CONSTIPATION. IN AN ADDITIONAL FOLLOW-UP CALL, THE CLINIC MANAGER CONFIRMED THAT THE PATIENT HAD BEEN HAVING ONGOING CONCOMITANT CONSTIPATION, PRIOR TO HOSPITALIZATION. IT WAS STATED THAT THE CONSTIPATION IMPEDED THE PATIENT¿S ABILITY TO DRAIN FROM THE PD CATHETER (NOT A FRESENIUS PRODUCT) DURING THE PD TREATMENT. AS A RESULT, ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED FOR FLUID VOLUME OVERLOAD. THE CLINIC MANAGER HAD LIMITED INFORMATION TO PROVIDE ABOUT THE HOSPITALIZATION AND THE DISCHARGE SUMMARY WAS NOT AVAILABLE. HOWEVER, IT WAS REPORTED THAT WHILE THE PATIENT WAS HOSPITALIZED, THEY RECEIVED DIALYSIS (TREATMENT DETAILS ARE UNKNOWN). ADDITIONALLY, THE PATIENT¿S CONSTIPATION WAS TREATED (DETAILS UNKNOWN). SUBSEQUENTLY, ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL CONTINUING PD TREATMENT ON THE FRESENIUS CYCLER. THE CLINIC MANAGER STATED THE HOSPITALIZATION FOR FLUID VOLUME OVERLOAD WAS LIKELY FROM THE PATIENT¿S CONCOMITANT CONSTIPATION WHICH WAS CAUSING ONGOING DRAIN COMPLICATIONS DURING THE PD TREATMENT.
ON 30/NOV/2022, A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT ON PD THERAPY WAS PREVIOUSLY HOSPITALIZED FOR FLUID RETENTION WITH REPORT OF CONSTIPATION. IN AN ADDITIONAL FOLLOW-UP CALL, THE CLINIC MANAGER CONFIRMED THAT THE PATIENT HAD BEEN HAVING ONGOING CONCOMITANT CONSTIPATION, PRIOR TO HOSPITALIZATION. IT WAS STATED THAT THE CONSTIPATION IMPEDED THE PATIENT¿S ABILITY TO DRAIN FROM THE PD CATHETER (NOT A FRESENIUS PRODUCT) DURING THE PD TREATMENT. AS A RESULT, ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED FOR FLUID VOLUME OVERLOAD. THE CLINIC MANAGER HAD LIMITED INFORMATION TO PROVIDE ABOUT THE HOSPITALIZATION AND THE DISCHARGE SUMMARY WAS NOT AVAILABLE. HOWEVER, IT WAS REPORTED THAT WHILE THE PATIENT WAS HOSPITALIZED, THEY RECEIVED DIALYSIS (TREATMENT DETAILS ARE UNKNOWN). ADDITIONALLY, THE PATIENT¿S CONSTIPATION WAS TREATED (DETAILS UNKNOWN). SUBSEQUENTLY, ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL CONTINUING PD TREATMENT ON THE FRESENIUS CYCLER. THE CLINIC MANAGER STATED THE HOSPITALIZATION FOR FLUID VOLUME OVERLOAD WAS LIKELY FROM THE PATIENT¿S CONCOMITANT CONSTIPATION WHICH WAS CAUSING ONGOING DRAIN COMPLICATIONS DURING THE PD TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2010903 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention| H | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET | LIBERTY CYCLER SET | LIBERTY CYCLER SET |