MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA

Model Number	6300
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during infusion it was detected air and occlusion problem.Patient adverse effects are unknown.
Additional Manufacturer Narrative
Device evaluation: the suspected device was returned for evaluation.The customer reported issue of ¿during infusion it was detected air and occlusion problem¿ was duplicated.The downstream occlusion (dso) sensor was out of specification (worn).There was no problem with the air detector.The dso sensor was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD LEGACY PCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25149001
• Report Number: 3012307300-2026-04852
• Device Sequence Number: 21518982
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: (01)10610586019357(11)040617
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown