MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7002-24
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was duplicated.Upon closer inspection under magnification, particulate matter is observed to be in the fluid path (within the bag).After investigation the results indicated a reportable malfunction due to the particulate matter observed in the fluid path, within the cassette bag.The particle was ball-shaped and seemed to be made of a silicone-like substance.It was measured to be 0.8mm^2.The results show the sample most consistent with polycarbonate/acrylonitrile butadiene styrene (abs) blend at 55.0% percent.Overall, the fourier transform infrared spectroscopy (ftir) results were inconclusive in determining the substance of the particulate matter found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.
Event or Problem Description
The customer returned the product for "floaters", and during physical inspection it was found that a particulate matter was observed in the fluid path, within the cassette bag.After investigation the results indicated a reportable malfunction due to the particulate matter observed in the fluid path, within the cassette bag.The event occurred during set up at clinic, and there was no patient involvement.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22938032
• Report Number: 3012307300-2025-10217
• Device Sequence Number: 18587790
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)290818(10)6037753
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K843772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 21-7002-24
• Device Lot Number: 6037753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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