NIMBUS II PLUS AMBULATORY INFUSION PUMP

Additional Manufacturer Narrative

ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 3/26/2024. THE RESULTS ARE BELOW: DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM WAS DUPLICATED. THE PUMP WAS POWERED ON, AND DURING POST, THE PUMP DID NOT MAKE ANY SOUND. EACH KEY WAS PRESSED, AND THE PUMP DID NOT MAKE ANY SOUND AT ANY POINT.

Description of Event or Problem

ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD "SPEAKER MODULE NO SOUND," CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THE PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. DEVICE RETURN REQUESTED. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.