MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD MEDICATION CASSETTE; PUMP, INFUSION

Catalog Number	21-7001-24
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 total volume was 153 ml.The pump finished 8 hours early saying there was still 53 ml in cassette.The cassette was empty.The amount of medication remaining in cassette/bag did not match the reservoir volume displayed on pump.There was patient involvement, but no patient harm was reported.
Additional Manufacturer Narrative
H3: the device was received for evaluation.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Visual and functional tests were performed.The customer's stated problem was not confirmed.The device was delivering properly.There was no known cause of the reported issue, and no further action will be taken.

• Brand Name: CADD MEDICATION CASSETTE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22714218
• Report Number: 3012307300-2025-09294
• Device Sequence Number: 15801165
• Product Code: FRN
• UDI-Device Identifier: 10610586022111
• UDI-Public: (01)10610586022111(17)290611(10)6022008
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K843772
• 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,Followup
• Report Date (Section B): 09/29/2025

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 Catalogue Number: 21-7001-24
• Device Lot Number: 6022008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown