MAUDE Adverse Event Report: ICU Medical, Inc. CADD Legacy PCA Pumps; Pump, Infusion, Pca

Model Number	6300
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump generated a "high pressure (hi-p)" alarm.The issue could not be resolved, and the pump was not running at the conclusion of the call.The medication being infused was ropivacaine; however, the programmed infusion rate, remaining volume, and volume infused could not be obtained.The event occurred during infusion.There was patient involvement; however, no patient harm was reported.
Additional Manufacturer Narrative
Device has not been returned to manufacturer.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.

• Brand Name: CADD Legacy PCA Pumps
• Common Device Name: Pump, Infusion, Pca
• Manufacturer (Section D): ICU Medical, Inc.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50869652
• Report Number: 3012307300-2026-08900
• Device Sequence Number: 9223557
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: (01)10610586019449(11)200120
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: Lay User/Patient
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Ropivacaine, Unk Mfr
• Patient Sex: Unknown