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

Catalog Number	21-7324-24
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
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 stated that either the epidural pump tubing or pump or both malfunctioned 7 hours into the epidural running appropriately.Epidural started at 0748 and ran well with no issues, patient had no pain.At 1417, new bag was hung due to low reservoir volume.At this time, patient pain was increasing and rn noticed that about half of the bag was still full rather than the smaller amount of reservoir volume that the pump stated.The pump then alarmed that there was an occlusion and air in the line when there was no occlusion or air.With the patients increase in pain, the increase in reservoir volume from what the pump said, the occlusion and air in line which was not accurate, the pump and pump tubing was replaced immediately.There was a patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D3 - mfg establishment name and address: corrected.D4 - lot #, expiration date, primary udi number: updated.H3 and h6 codes - updated.H4 - device mfg date: updated.One used device was returned for investigation.The devices were visually inspected and no damage or anomalies were observed.During functional testing, no alarms, leakage or difficulties priming were observed.The customer reported complaint could not be replicated or confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A root cause was unable to be determined.

• 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; industrial int'l tijuana; tijuana MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21028745
• Report Number: 3012307300-2024-15545
• Device Sequence Number: 4223441
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: (01)10610586029653(17)290321(10)4468631
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 21-7324-24
• Device Lot Number: 4468631
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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