MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD LEGACY PCA PUMPS; 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	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump had a high-pressure alarm during testing and was due to a damaged downstream occlusion (dso) sensor.There was no patient involvement and harm.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.Visual inspection was performed and was confirmed that there were no anomalies noted with respect to the complaint.The event history log (ehl) was reviewed.The high-pressure alarm was noted and confirmed in the ehl as stated by the complainant.The service history review was performed, and it was confirmed that there was no previous repair noted.The dso test was performed, and it was confirmed that the sensor was damaged.The allegation made by the complainant was confirmed.The probable root cause of the event was due to the damaged dso sensor and was then replaced.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25512226
• Report Number: 3012307300-2026-06118
• Device Sequence Number: 21470846
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: (01)10610586019449(11)210419
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown