MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 the cassette was leaking.Since the clamp was closed close to the cartridge after filling, one must probably assume a leak at the bag seam or at the transition between the bag and the tube.The cassette did not show any abnormalities in the final inspection, shortly after filling.The leak only became apparent after a few days, during which the cassette was still in storage.There was no patient involvement, as no application took place.
Additional Manufacturer Narrative
H3: the device was received for evaluation, along with two customer-provided images showing the sample submerged in medication fluid.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Visual and functional testing identified a leak at side d of the cassette bag seam.Further inspection under magnification revealed an opening caused by seam delamination.The probable cause was determined to be inconsistent sealing die power and adjustments impacting seal strength.No further action was taken.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23850297
• Report Number: 3012307300-2025-13631
• Device Sequence Number: 15906880
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)300309(10)6092851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K843772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Model Number: 7002
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 6092851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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