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 Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the product, for something strange was noticed while filling out the route.During device evaluation, a leak and downstream occlusion alarm were identified.There was no reported patient harm/adverse event.
Additional Manufacturer Narrative
H3: one used product was received for evaluation.Visual inspection identified no damage or anomalies.Functional testing was performed where the extension set was attached to a 100ml cassette filled with red dye provided by icu medical and inserted into a cad solis pump.The set was attempted to be primed with 10 ml.As a result, a "downstream occlusion.Clear occlusion between pump and patient" alarm was returned temporarily and then cleared.When priming was reinitiated, the alarm then repeated.Additionally, a leak was observed at the incoming filter tube bond.Further inspection showed a solvent channel.In attempts to pinpoint the cause of the alarm, the asv luer was cut off and priming was reattempted.A "downstream occlusion.Clear occlusion between pump and patient" alarm was returned temporarily.The filter was cut off and priming was reattempted.No alarms or difficulties priming were observed.In attempts to visualize the source of occlusion red dye was attempted to be pushed through the inlet side of the filter.Resistance was observed.Fluid made it through the inlet side of the filter, but resistance was felt at the outlet.Inspection of the tube/filter bond sites showed no damage or anomalies.The customer¿s complaint was confirmed due to the temporary occlusion alarms and leakage.The probable cause of the occlusion alarm is due to a supplier error, and the probable cause of the leak is due to a solvent coverage application error during assembly in tijuana.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• 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: 23827979
• Report Number: 3012307300-2025-13569
• Device Sequence Number: 12029010
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: (01)10610586023279(17)280202(10)4365475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 21-7106-24
• Device Lot Number: 4365475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown