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

Catalog Number	21-7309-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 there was leakage at the seam of the bladder.It was found out upon lot receipt or after delivery.There was no patient involvement or patient harm.
Additional Manufacturer Narrative
A1: updated.D3, d5: updated.H3 and h6 codes: updated.Three (3) samples and fourteen (14) images were returned for evaluation.Lot history review identified no nonconformities related to the complaint.Fourteen (14) images were returned showing multiple cassettes and leak sites on the cassette bags.Visual inspection confirmed the reported leak locations, with one cassette bag found torn open.Functional testing confirmed leakage in all three samples.Sample 1 leaked from corner 2, with damage consistent with side-panel closure during compounding.Sample 2 exhibited leakage due to the bag being extensively torn open.Sample 3 leaked from corner 3, originating from the cassette bag seam.The complaint of leakage was confirmed.The probable cause for sample 1 was damage to the bag seam during side-panel closure; the probable cause for samples 2 and 3 could not be determined.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4, parque; tijuana MN 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25178499
• Report Number: 3012307300-2026-05042
• Device Sequence Number: 21468447
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: (01)10610586032387
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081156
• 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): 07/10/2026

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: Other
• Device Catalogue Number: 21-7309-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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