PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR VISUAL INSPECTION OF THE RETURNED CYCLER SHOWED NO SIGNS OF PHYSICAL DAMAGE. THE CYCLER TOUCH SCREEN TEST FAILED. WHEN POWERING ON THE CYCLER, THE OK, STOP AND UP/DOWN ARROW PUSH BUTTONS ILLUMINATED, HOWEVER THE FRONT PANEL TOUCH SCREEN REMAINED BLANK. IT WAS IDENTIFIED THAT THE CAUSE FOR THE BLANK SCREEN WAS DUE TO AN INTERNAL SHORT PRESENT TRANSFORMER (T1) ON THE INVERTER BOARD. A KNOWN GOOD INVERTER BOARD WAS INSTALLED AND THE DISPLAY BECAME FULLY OPERATIONAL. THE VALVE ACTUATION TEST FAILED DUE TO THE RESERVOIR PRESSURE TANK LEAKING. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO OTHER DISCREPANCIES. 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 CYCLER FAILED THE POST ACCELERATE STIMULATED TREATMENT DUE TO A DIM DISPLAY. THE CYCLER WAS REWORKED AND THE FRONT PANEL WAS REPLACED. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT ON TRANSFORMER ON THE INVERTER BOARD. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.
D
Patient 1
IT WAS REPORTED THAT THE SCREEN OF A PATIENT?S LIBERTY SELECT CYCLER WENT BLANK DURING AN UNKNOWN PHASE OF THEIR PERITONEAL DIALYSIS (PD) TREATMENT. THE POWER CORD WAS PROPERLY CONNECTED IN BOTH ENDS AND CYCLER PLUGGED DIRECTLY INTO A THREE PRONG WALL OUTLET THAT WAS SHARED WITH THE MODEM. THE PATIENT RECEIVED AN UNKNOWN ALARM. THE OK AND STOP KEYS WERE PRESSED AND SCREEN WAS TOUCHED, HOWEVER THE SCREEN REMAINED BLANK. THE OK AND STOP KEYS MADE A SOUND WHEN PRESSED, CYCLER WAS REBOOTED, OK AND STOP KEYS ILLUMINATED, BUT SCREEN REMAINED BLANK. AT THAT POINT IN TIME, 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. A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THAT THERE WERE NO ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT COMPLETE TREATMENT. THE CYCLER WAS RETURNED TO THE MANUFACTURER. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, EVIDENCE OF AN INTERNAL SHORT ON THE TRANSFORMER ON THE INVERTER BOARD WAS IDENTIFIED.
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)