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

Catalog Number	21-7310-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cassette reservoir had a puncture.There was no patient involvement or harm.
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.
Additional Manufacturer Narrative
H3: no product was returned but a video was attached to the complaint.The video showed a leak from the inner bag of the cassette, but it was unclear if the leak was coming from the seam of the bag or the hole.The complaint of puncture can be confirmed based on the returned video, however, without the return of the sample used a comprehensive failure investigation cannot be performed, and a cause cannot be determined.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.
Additional Manufacturer Narrative
Corrected data: d3 - mfg establishment name.The suspected device was returned for evaluation.The device was visually inspected and there were no damages.A functional test was performed and the reported issue was confirmed.The probable cause of the reported issue was due to unintentional damage to the bag seam when closing the side panel during compounding.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD CASSETTE RESERVOIRS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22412006
• Report Number: 3012307300-2025-07928
• Device Sequence Number: 18590645
• Product Code: FPA
• UDI-Device Identifier: 10610586032394
• UDI-Public: (01)10610586032394(17)290506(10)6005567
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 21-7310-24
• Device Lot Number: 6005567
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 01/06/2026
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/11/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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