MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7391
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that they are getting upstream occlusion alarm on the pumps.There was no patient involvement.
Additional Manufacturer Narrative
H6.Codes: updated.The customer sent a picture that shows the pump deploying an alert about an occlusion in the medical device.The customer reported problem can´t be confirmed due the alarm showed in the picture, and the device evaluation can´t be performed since the samples reported were not received and there´s no picture to evaluate or confirm that product presented the condition reported.A retrospective review was performed for a period of july 2024 to july 2025 and there are no complaints related to the same part number or lot number.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22198144
• Report Number: 3012307300-2025-06981
• Device Sequence Number: 8593985
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: (01)10610586027512(17)300201(10)6085310
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Model Number: 7391
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 6085310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: Unknown