MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. CADD Medication Cassette Reservoir; Set, administration, intravascular

Catalog Number	21-7301-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reservoir cassette exhibited holes in the ends of the red caps, resulting in product leakage and a loss of sterility.The issue was identified after compounding and charging the units.There was no patient involvement; therefore, no patient harm was reported.
Additional Manufacturer Narrative
B3 - date of event is unknown.Therefore, the first day and the month of the icu medical awareness date was used.The root cause investigation analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: CADD Medication Cassette Reservoir
• 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 NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 600 north field drive; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50869501
• Report Number: 9617604-2026-00928
• Device Sequence Number: 10743157
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 21-7301-24
• Device Lot Number: 6176719
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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