CADD LEGACY PCA PUMPS

Additional Manufacturer Narrative

H3/H6: 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 INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE ALARM IS CONTINUOUSLY SOUNDING AND DOES NOT DEACTIVATE. THE EVENT OCCURRED WHILE PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H3: THE DEVICE WAS RECEIVED FOR EVALUATION. ICU MEDICAL JAPAN HAS RECEIVED ONE REPAIR REQUEST IN THE PAST YEAR. THE MOST RECENT REPAIR REQUEST WAS MADE ON 2025-JAN-20 (RO#1401592). VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, WHICH FOUND THE ROOT CAUSE OF THE EVENT WAS AN ANOMALY IN THE GEAR OF THE MOTOR. THE DEVICE WAS RETURNED TO THE CUSTOMER WITH NO REPAIR PROVIDED AT THEIR REQUEST.