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	04/09/2026
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 cadd legacy pca pump alarmed with no disposable (nd) alarm and would not run.The pump was powered off and on and an attempt was made to restart it, but it continued to alarm with nd and pump would not run.The device stopped functioning while medication remained to be delivered, resulting in interruption of therapy and potential under delivery of medication.The medication being infused was ropivicaine with programmed rate at 7 ml per hour, the remaining volume was 400 ml, and the volume given was 164 ml.There was patient involvement, and no patient injury/ harm reported.
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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25068133
• Report Number: 3012307300-2026-04517
• Device Sequence Number: 18820106
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: (01)10610586019449(11)190319
• 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: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: Lay User/Patient
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVICAINE, UNK MFR
• Patient Sex: Unknown