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

Catalog Number	21-7308-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a cadd reservoir cassette where it was reported that two reservoir cassettes triggered a downstream occlusion alarm, immediately upon pump start-up (cadd solis in continuous mode).The reporter stated that the clamp was handled correctly and the extension line was correctly oriented.Multiple attempts to remove and reinstall the cassette were unsuccessful.The cassette (250 ml) and the pump were subsequently replaced.The pump is not at fault (the cassette shows the same defect on several pumps, and other cassettes do not trigger any alarm on the current pump).The pump was programmed in continuous mode over 24 hours.There was patient involvement, and a delay in therapy of one hour but no harm reported.This may stop delivery and lead to under infusion which may lead to any hazardous situation to the patient while infusion.This report captures the second of two reservoirs.
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.

• Brand Name: CADD MEDICATION CASSETTE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4, parque; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25469350
• Report Number: 3012307300-2026-05948
• Device Sequence Number: 9933409
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: (01)10610586032370(17)280112(10)4354493
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 21-7308-24
• Device Lot Number: 4354493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TAZOCILLIN, UNK MFR
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG