CADD CASSETTE RESERVOIRS - FLOW STOP

Additional Manufacturer Narrative

B3: MONTH AND YEAR VALID. PER REPORTER, THE EVENT OCCURRED IN LATE JULY. H3: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

Description of Event or Problem

IT WAS REPORTED THAT THE CASSETTE HAD LIQUID LEAKAGE. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

ONE OPENED/UNUSED SAMPLE WAS RECEIVED ALONG WITH A SYRINGE AND AN EXTENSION SET. IN AN ATTEMPT TO REPLICATE CLINICAL USE, THE CASSETTE BAG WAS FILLED TO TRY AND IDENTIFY ANY LEAKAGE. NO LEAKAGE WAS OBSERVED. THE CASSETTE LEAKAGE CANNOT BE REPLICATED OR CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.