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

Model Number	6300
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that the pump alarmed for upstream occlusion, and it could not be resolved.The event occurred during infusion, with patient involvement and no harm.
Additional Manufacturer Narrative
H3 and h6 codes - updated.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD LEGACY PCA PUMPS
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25183032
• Report Number: 3012307300-2026-05061
• Device Sequence Number: 18830330
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: (01)10610586019449(11)181003
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 21-6300-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1667-1668-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown