PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
D
Patient 1
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT ENCOUNTERED A FLUID LEAK FROM WITHIN THE CYCLER'S CASSETTE COMPARTMENT DURING DRAIN 2 OF PD TREATMENT. THE PATIENT REPORTED RECEIVING AIR DETECTED IN CASSETTE ALARMS TWICE DURING DRAIN 2. THE LEAK BEGAN DURING DRAIN 2 OF TREATMENT. THE SOURCE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE CYCLER. 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 TREATMENT WAS COMPLETED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). 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.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)