LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 2937457-2022-00348
- Event Type
- Death
- Date Received
- March 4, 2022
- Date of Event
- February 21, 2022
- Report Date
- March 31, 2022
- 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: THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION OR DEFICIENCY REPORTED FOR THIS EVENT. THERE IS NO INDICATION OF A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT RELATED TO A FRESENIUS PRODUCT OR OTHER ISSUE WARRANTING FURTHER INVESTIGATION.
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 AND ON THE PUMP DOOR. 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 ON THE CYCLER AND COMPLETED WITHOUT FAILURES. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE FOR A LIBERTY CYCLER. NO FLUID LEAKS IN THE TEST CASSETTE DURING THE TREATMENT TEST. THE CYCLER UNDERWENT AND PASSED A CATCH-POST HIPOT TEST, PATIENT HIPOT TEST, CURRENT LEAKAGE TEST, SYSTEM AIR LEAK TEST, VALVE ACTUATION TEST, VOLTAGE CALIBRATION CHECKS AND PATIENT SENSOR CALIBRATION CHECK. AN INVESTIGATION OF THE CYCLER MUSHROOM HEADS VERIFIED THAT THE SURFACE CONDITIONS AND ALIGNMENTS WERE WITHIN SPECIFICATION. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER UNDER THE PUMP. 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.
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.
IT WAS REPORTED THIS PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY BUT WAS FOUND AT A LATER DATE. THE CAUSE OF DEATH AND DATE OF DEATH WERE UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME OF DEATH. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS FOUND DECEASED ON THE FLOOR ON (B)(6) 2022 AFTER A WELL-BEING CHECK CONDUCTED BY THE POLICE AT THE FAMILY¿S REQUEST. IT WAS NOT CONFIRMED IF THE PATIENT WAS CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME; HOWEVER, A REVIEW OF THE PATIENT¿S IQ DRIVE SHOWS THE LAST PD TREATMENT DOCUMENTED WAS (B)(6) 2022. THE PDRN STATED THE AUTOPSY RESULTS WERE STILL PENDING THUS A DATE AND CAUSE OF DEATH WERE STILL UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.
IT WAS REPORTED THIS PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY BUT WAS FOUND AT A LATER DATE. THE CAUSE OF DEATH AND DATE OF DEATH WERE UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME OF DEATH. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS FOUND DECEASED ON THE FLOOR ON (B)(6) 2022 AFTER A WELL-BEING CHECK CONDUCTED BY THE POLICE AT THE FAMILY¿S REQUEST. IT WAS NOT CONFIRMED IF THE PATIENT WAS CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME; HOWEVER, A REVIEW OF THE PATIENT¿S IQ DRIVE SHOWS THE LAST PD TREATMENT DOCUMENTED WAS (B)(6) 2022. THE PDRN STATED THE AUTOPSY RESULTS WERE STILL PENDING THUS A DATE AND CAUSE OF DEATH WERE STILL UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.
IT WAS REPORTED THIS PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY BUT WAS FOUND AT A LATER DATE. THE CAUSE OF DEATH AND DATE OF DEATH WERE UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME OF DEATH. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS FOUND DECEASED ON THE FLOOR ON (B)(6) 2022 AFTER A WELL-BEING CHECK CONDUCTED BY THE POLICE AT THE FAMILY¿S REQUEST. IT WAS NOT CONFIRMED IF THE PATIENT WAS CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME; HOWEVER, A REVIEW OF THE PATIENT¿S IQ DRIVE SHOWS THE LAST PD TREATMENT DOCUMENTED WAS (B)(6)2022. THE PDRN STATED THE AUTOPSY RESULTS WERE STILL PENDING THUS A DATE AND CAUSE OF DEATH WERE STILL UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216111 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Death| L | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET |