MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD LEGACY PCA PUMP; 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	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The reported issue was verified in the event history log.Visual and functional tests were performed.The customer's problem was duplicated.The cause of the issue was a defective mainboard.The mainboard was replaced to fix the issue.
Event or Problem Description
It was reported that the device displayed error code lec1280.The event occurred during setup and there was no patient involvement.

• Brand Name: CADD LEGACY PCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25301891
• Report Number: 3012307300-2026-05430
• Device Sequence Number: 9517190
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: (01)10610586019449(11)191017
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown