MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD MS3 PUMPS; PUMP, INFUSION

Model Number	7400
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that device had been undergoing infusion therapy for the treatment of pulmonary arterial hypertension with remodulin (treprostinil).Patient reported pump alarms and attempted multiple reloads and restarts, but alarms recurred.Patient delayed reporting, thinking it might be her fault.Later, noted clear threads on pump were broken and intermittently blood visible in the line.Pump history showed only 0.5 ml remodulin infused over 2.5 days at rate of 0.034 ml per hr.Patient reported no noticeable changes in condition.Clinic rn adjusted her infusion rate to slowly titrate her back to full dose to prevent adverse event.Event occurred during while in use with patient and operator of device was patient and event occur at patient home.There was no patient involvement and reported no harm.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.Based on the review of the service history and information provided from the customer we are unable to determine a probable cause as the device was not returned for evaluation.No event history log provided.

• Brand Name: CADD MS3 PUMPS
• Common Device Name: PUMP, INFUSION
• 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: 24705774
• Report Number: 3012307300-2026-02989
• Device Sequence Number: 21442524
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: (01)10610586029554(17)141231(10)451017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051568
• 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,Followup
• Report Date (Section B): 05/11/2026

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: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown