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

Catalog Number	21-7106-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
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 increasing difficulty in removing the cassette from one of her infusion pumps, identified by serial number.Despite attempting troubleshooting, the issue persisted and worsened over time.As a result, the patient switched to a backup pump, which has been functioning without any issues.The affected pump was used during a continuous infusion, although the specific flow rate and volume delivered are unknown.The position of the pump at the time of the alarm is also unknown.The patient confirmed that the product fault occurred while the device was in use, but it did not cause or contribute to any clinical injury.The actual device is available for investigation and was replaced upon return.The patient had a backup device and was able to successfully continue her life-sustaining infusion therapy.Additionally, the patient experienced an occlusion alarm last month related to one of her extension tubings.The issue was resolved after replacing the tubing.The affected product had a lot number of 6108409, but the expiration date is unknown.No photographs were provided, and pump return tracking information is not available.The outcome of the event is considered resolved.The patient code is 2422, and the associated device codes are 1528 and 1012.This incident is documented under reference report mw5177717.
Additional Manufacturer Narrative
Device evaluation: no product returned for device analysis; a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: CADD EXTENSION 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23696380
• Report Number: 3012307300-2025-13044
• Device Sequence Number: 9082731
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: (01)10610586023279(11)300423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 21-7106-24
• Device Lot Number: 6108409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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: Female