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

Catalog Number	21-7357-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of reported lot number was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.The reported complaint was unable to be confirmed due to samples not being returned.Photos were not provided to confirm reported failure mode.Testing was not conducted for the investigation.If the product is returned at a later date, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that fluid soaked through patient's infusion backpack during infusion (about 13 hours into 16 hour infusion).Infusion was discontinued and remainder of solution was discarded due to concern for contamination.Leaking occurred on the downstream side of the pump.There was a delay in therapy.There was no adverse/harm event reported.The product is not contaminated and does not contain a biohazard or chemotherapeutic agent.The medication used was parenteral nutrition without lipids.No patient harm was reported.

• 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: 22203009
• Report Number: 3012307300-2025-07014
• Device Sequence Number: 12453777
• Product Code: FPA
• UDI-Device Identifier: 10610586027390
• UDI-Public: (01)10610586027390(17)300115(10)6077893
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 21-7357-24
• Device Lot Number: 6077893
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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