MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA

Model Number	6300
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump indicated 3 attempts / 1 bolus administered.No administration schedule appeared.The elements collected point to a malfunction of the bolus pear button contactor: the pear was well recognized by the pump.On the other hand, she no longer transmitted the bolus administration order.The patient was unable to receive a bolus of midazolam as part of a care of a respiratory decompensation on cancer orl.Test with the configuration used in the patient.The background dose was working normally.The bolus could not be delivered, despite the pressures on the pear.Test after replacement of the bolus bulb.An alarm was triggered as soon as the old bulb was removed, showing that the pump correctly detected the presence/absence of the accessory.The bolus then administered normally.The bolus counter updated as expected.There was patient involvement.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were added.One device was returned for investigation.It was reported that the pump indicated 3 attempts / 1 bolus administered.No administration schedule appeared.No defects/discrepancies were noted.The cause of the reported issue was unable to be determined.The device has been submitted for functional and accuracy testing and to confirm resolution of the reported issue.Complaints with higher priority were addressed first based on volume and aging.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: CADD LEGACY PCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24079765
• Report Number: 3012307300-2026-00360
• Device Sequence Number: 17596482
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: (01)10610586019357(11)121113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 21-6300-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2012
• 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
• Patient Age: 56 YR
• Patient Sex: Female