MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7394-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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 the patient came for a cadd unhook.The chemotherapy pump showed 4.6mls left to be infused and cadd pump was primed.When they were looking at the chemotherapy medication bag, there were approximately 100mls left.As they double checked, the rate of 20.8 milliliters per hour was programed correctly with a volume of 500 milliliters.The starting volume was 500 ml.A continuous infusion rate of 20.8 ml per hour had been programmed.Reservoir volume: pump stated there were 4.6ml left at time of disconnect (24 hours after hooking up) but 100ml left in bag.Given volume: pump stated 495.6ml (as 4.6ml left) but only about 400 ml was given.The amount of the medication remaining in cassette did not match the reservoir volume displayed on pump.They switched out the pump and utilized the same cassette.They took about 3 hours at 33.3ml per hour.The amount remaining was 100ml.The length of infusion took 27 hours because of an increased rate at the end (33.3ml per hour).A closed system transfer device was used to fill the cassette.They had to increase patient's chemotherapy rate to complete by the time the clinic closed.The event occurred while in use with patient.There was no patient harm.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24248962
• Report Number: 3012307300-2026-00842
• Device Sequence Number: 8309587
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• 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): 07/16/2026

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 Catalogue Number: 21-7394-24
• Device Lot Number: 6102262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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 Sex: Unknown