CADD - SOLIS AMBULATORY PUMP, MODEL 3.0

Additional Manufacturer Narrative

H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO A PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE WITH THE BATTERY COMPARTMENT DAMAGED; THE TAMPER SEAL WAS MISSING. THERE WAS NO EVIDENCE OF THE REPORTED ERROR IN THE EVENT HISTORY LOG. THE REPORTED PROBLEM WAS NOT DUPLICATED DURING FUNCTIONAL TEST; FOUND THAT THE UPSTREAM SENSOR AND DOWNSTREAM SENSOR CALIBRATED WITHOUT ANY ISSUES HOWEVER, USING IN HOUSE PRESSURE TEST THE DOWNSTREAM SENSOR FAILED TO ALARM WHEN THE TUBING WAS CLAMPED. THE DEVICE ALSO ALARMED CASSETTE NOT ATTACHED PROPERLY WHEN NO CASSETTE WAS ATTACHED. FOR CORRECTIVE ACTION, THE DOWNSTREAM SENSOR WAS REPLACED. THE ROOT CAUSE WAS UNKNOWN. THE PRODUCT IS BEYOND A YEAR FROM ITS MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS # (B)(4). CORRECTION: D4: MODEL NUMBER:2110.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A RETURNED ORDER SERVICE THE DEVICE FAILED CALIBRATION. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.