LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

Report

Report Number: 2937457-2020-00425
Event Type: Malfunction
Date Received: March 3, 2020
Date of Event: February 19, 2020
Report Date: May 27, 2020
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

Additional Manufacturer Narrative · 0

CORRECTED INFORMATION: B5, D10, H3,- DEVICE NOT RETURNED FOR THE EVENT CAPTURED IN THIS REPORT (TRANSCRIPTION ERROR) D4- REMOVED MODEL AND LOT # (TRANSCRIPTION ERROR) H10- PLANT INVESTIGATION, H6- RESULTS, CONCLUSION- NO FURTHER PLANT INVESTIGATION RESULTS ARE EXPECTED (TRANSCRIPTION ERROR) 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.

Additional Manufacturer Narrative · 0

CORRECTED INFORMATION: H10 - INITIAL SHOULD HAVE INDICATED AS FOLLOWS: "THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. "(TRANSCRIPTION ERROR) PLANT INVESTIGATION: THE PLANT IS PENDING THE RETURN OF THE REPORTED CYCLER FOR A PHYSICAL EVALUATION. IN THE INTERIM, 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 NONCONFORMANCES, 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 IS PENDING THE COMPLETION OF A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD PREVIOUSLY ENCOUNTERED A FLUID LEAK FROM THE CYCLER¿S CASSETTE COMPARTMENT WHEN REMOVING THE CASSETTE FROM THE CYCLER AT THE END OF PD TREATMENT. IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE CYCLER ON THE DATE OF THE OCCURRENCE BUT SHE DID NOT CALL FRESENIUS TECHNICAL SUPPORT ON THAT DATE, THEREFORE, THE CYCLER WAS NOT RETURNED FOR THE EVENT CAPTURED IN THIS REPORT. A NEW CYCLER WAS ISSUED TO THE CUSTOMER TWO DAYS LATER AFTER THEY REPORTED A SIMILAR OCCURRENCE ON (B)(6) 2020. UPON FOLLOW UP, THE PATIENT REPORTED THAT SHE WAS RECEIVING MULTIPLE PATIENT LINE IS BLOCKED ALARMS AND AIR DETECTED IN CASSETTE ALARMS DURING UNKNOWN PHASES AFTER DRAIN 0. SHE INDICATED THAT SHE CANCELLED TREATMENT BECAUSE SHE WAS UNABLE TO BYPASS THESE ALARMS AND IT WAS WHEN SHE WAS REMOVING THE CASSETTE THAT SHE NOTICED THE FLUID LEAK. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE SOURCE OF THE LEAK IS A PINHOLE ON THE CASSETTE¿S THIN FILM OVER THE DOMES. TREATMENT WAS COMPLETED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) ON THE DATE OF THE EVENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE TO RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

Additional Manufacturer Narrative · 1

K181108.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD PREVIOUSLY ENCOUNTERED A FLUID LEAK FROM THE CYCLER¿S CASSETTE COMPARTMENT WHEN REMOVING THE CASSETTE FROM THE CYCLER AT THE END OF PD TREATMENT. IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE CYCLER ON THE DATE OF THE OCCURRENCE BUT SHE DID NOT CALL FRESENIUS TECHNICAL SUPPORT ON THAT DATE. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THE CYCLER AND FOLLOW UP WITH THE PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE CUSTOMER. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT REPORTED THAT SHE WAS RECEIVING MULTIPLE PATIENT LINE IS BLOCKED ALARMS AND AIR DETECTED IN CASSETTE ALARMS DURING UNKNOWN PHASES AFTER DRAIN 0. SHE INDICATED THAT SHE CANCELLED TREATMENT BECAUSE SHE WAS UNABLE TO BYPASS THESE ALARMS AND IT WAS WHEN SHE WAS REMOVING THE CASSETTE THAT SHE NOTICED THE FLUID LEAK. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE SOURCE OF THE LEAK IS A PINHOLE ON THE CASSETTE¿S THIN FILM OVER THE DOMES. TREATMENT WAS COMPLETED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) ON THE DATE OF THE EVENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE TO RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE REPORTED CYCLER HAS BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
243161	LIBERTY SELECT CYCLER ASSY(NON-VALUATED)	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	CONCORD MANUFACTURING	LIBERTY SELECT CYCLER	N/A	00840861102068

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR			DELFLEX PD FLUID.\| LIBERTY CYCLER SET.